PARTICIPANT INFORMATION AND INFORMED CONSENT FORM
Protocol Title: Pilot Decentralized, Direct-to-Patient Feasibility Study Assessing User Experience Following a Switch from the Subject’s Current Female Intermittent Catheter to GentleCath™ Air for Women (GCAFW) with FeelClean™ Technology
Protocol #: IC-25-467
Sponsor: Convatec Inc, 20 Maguire Road, Lexington, MA 02421
Principal Investigator: Janet Kandrevas, MD
Institution: 180 Medical
Address: 8516 NW Expressway, Oklahoma City, OK 73162
Telephone: 405-267-8436
KEY INFORMATION ABOUT THIS RESEARCH STUDY
You are being asked to be a participant in a research study because you are an adult woman who empties your bladder using intermittent catheters, receive your catheter supplies from 180 Medical in the United States, and may be willing to try a different intermittent catheter for 14 days.
The following table is a concise and focused presentation of key information to assist you in understanding why you might or might not want to participate in the research.
| Purpose | This research study will look at how adult women who already use intermittent urinary catheters experience a short-term switch from their current catheter to GentleCath™ Air for Women (GCAFW), a compact hydrophilic single-use catheter that is already FDA cleared for routine use. The study also tests whether it is practical to run “decentralised” or “direct-to-patient” catheter studies through 180 Medical (for example, by using electronic consent, online questionnaires and direct shipment of products). You will not receive any experimental drugs or procedures as part of this study. |
| Voluntary Participation | Your decision to be in this study is voluntary. You may choose not to take part or to leave the study at any time without giving a reason. Your decision will not affect your usual medical care, relationship with 180 Medical, or access to catheter supplies and other benefits to which you are entitled. |
| Withdrawal | If you decide to be in this study and then change your mind, you can leave the study at any time without penalty. If you leave the study, the information already collected about you may still be used, as described in this form, so that the study results are reliable. No new information will be collected about you after you withdraw, except information needed for safety or quality reporting. |
| Length of Participation | The main procedures in the study include:
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| Procedures | The main procedures in the study include:
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| Risks | Taking part in this research may expose you to risks and side effects related to the study catheter, GentleCath™ Air for Women. These risks are similar to those of your usual intermittent catheter and can include:
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| Benefit | There is no guarantee that you will receive any direct benefit from being in this study. Some participants may find that they prefer the GentleCath™ Air for Women catheter compared with their current catheter, but this cannot be promised. The information collected may help improve future catheter studies and may help improve products for people who use intermittent catheters in the future. |
| Alternatives to Study Participation | If you choose not to take part in this study, you can continue using your current intermittent catheter or any other catheter recommended by your healthcare provider. You may also discuss other catheter options or bladder management strategies with your provider. Your usual care and access to catheter supplies will not be affected by your decision about this study. |
| Costs | There is no cost to you for taking part in this study. The study sponsor will provide the GentleCath™ Air for Women catheters used during the 14-day study period at no charge to you. You and/or your insurance will remain responsible for the usual costs of your routine medical care and catheter supplies outside of the 14-day study period. You will automatically revert to your prior catheter after Day 14 by default. |
| Confidentiality | There are provisions in place by the study protocol and study site to help protect the privacy and confidentiality of your personal health information and study information. |
| This overview does not include all of the information you need to know before deciding whether or not to take part. Much additional detail is given in the full consent form, which can be found on the pages that follow. Be sure to review the rest of this consent form before deciding about participation. |
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INFORMED CONSENT FORM
This consent form explains the research study. Before you decide to be a part of this study, you need to know why the research is being done, what it will involve and the risks and benefits. Ask the study doctor and study staff to explain anything in this form or if you want more information. Please take time to read this form carefully. Feel free to discuss it with your relatives, friends and your primary care physician. If you agree to take part in this research study, you must sign this consent form.
DISCLOSURE OF FINANCIAL INTERESTS
Convatec (“the sponsor”) is funding and organizing this research study. The study is carried out using 180 Medical, a durable medical equipment (DME) supplier that is a wholly owned subsidiary of Convatec. 180 Medical routinely supplies intermittent catheters to patients as part of their standard treatment. They will help with identifying potentially eligible participants, delivering study catheters to your home, and supporting remote study data collection.
180 Medical will not receive any additional payment from the sponsor for each person who takes part in this study. The study doctor and research staff may receive a salary or other monetary support from the sponsor or institution related to their research duties, but they do not receive bonuses based on whether you join the study or what your questionnaire responses show.
Convatec and its subsidiaries may benefit in the future if the information from this study supports wider use of GentleCath™ products. You will not receive any share of these potential future benefits.
PURPOSE OF THE STUDY
The purpose of this study is to evaluate how practical and feasible it is to conduct “direct-to-patient” and decentralized research through 180 Medical to assess how adult women who are currently using intermittent urinary catheters experience a 14-day switch from their current catheter to GentleCath™ Air for Women.
The decentralized research will be conducted by using electronic informed consent, by questionnaires being completed remotely, and by direct product shipment.
GentleCath™ Air for Women is a compact, hydrophilic, single-use intermittent catheter that is already cleared and marketed for routine use.
In particular, the study will ask about comfort, ease of use, cleanliness, catheter-related discomfort, and urinary symptoms, and will help identify which patient-reported questions are most sensitive for evaluating catheters with FeelClean™ Technology.
NUMBER OF PARTICIPANTS AND LENGTH OF STUDY PARTICIPATION
About 40 women are expected to take part in this study at a single research site that operates in a direct-to-patient manner through 180 Medical in the United States.
Your participation in this study is expected to last about 2 to 3 weeks. During this time you will:
- Review and sign this consent form electronically
- Complete one online questionnaire before starting GentleCath™ Air for Women
- Use GentleCath™ Air for Women for 14 days instead of your usual intermittent catheter
- Complete one online follow-up questionnaire around Day 14 (or up to 3-days later).
STUDY PROCEDURES
If you choose to participate in the study, the following will happen:
- Screening:
- Consent: This consent form will be sent to you electronically to be reviewed.
- Pre-study screening call: You will receive a call from a member of the study team to discuss this consent form with you and ask brief questions to confirm that you are eligible to participate in the study. If you decide that you would like to participate in this study, you will sign this consent form electronically.
- Baseline (Day 0):
- Baseline questionnaire: You will be sent and will complete an online questionnaire about your current intermittent catheter and your experience using it.
- Catheter shipment: 180 Medical will ship a 14-day supply of GentleCath™ Air for Women (GCAFW) to your home.
- Use of GCAFW (Days 1–14):
- You will use GCAFW for all your intermittent catheterizations for 14 days, following the Instructions for Use and your usual schedule.
- You will use GCAFW for all your intermittent catheterizations for 14 days, following the Instructions for Use and your usual schedule.
- Follow-up questionnaire (Day 14 ±3 days):
- You will complete an online questionnaire about your experience with GCAFW (comfort, ease of use, problems, and preference). After completion of this questionnaire your participation in the study will be complete. You will return to using the catheter you use normally and your usual care, unless you and your healthcare provider decide otherwise outside of this research.
PARTICIPANT RESPONSIBILITIES
As a participant in this study, you will have certain responsibilities, including the following:
- Completing the questionnaires honestly and to the best of your ability.
- Using GCAFW as your only intermittent catheter for 14 days by following the Instructions for Use, unless your healthcare provider advises otherwise.
- Contacting your usual healthcare provider promptly if you experience concerning symptoms such as fever, chills, severe pain, or visible blood in the urine.
- Contacting the study helpdesk if you have non-urgent questions about the product or study procedures.
- Informing the study team if you decide you no longer wish to take part in this study.
RISKS AND DISCOMFORTS
Physical risks (catheter-related)
This study does not introduce new procedures beyond your usual intermittent catheterization. However, intermittent catheter use in general is associated with certain risks including:
- discomfort, stinging, or pain in the urethra during or after catheterization
- minor bleeding or spotting
- urinary tract infection (UTI)
- urethral irritation or trauma
In rare cases more serious injuries can occur such as a false passage or stricture.
You should contact your usual healthcare provider or seek emergency care for concerning symptoms such as fever, chills, severe pain, or heavy bleeding, and you may contact the study helpdesk for non-urgent questions. Participating in this study does not replace your usual medical care.
Device-specific risks
GCAFW is an FDA-cleared, sterile, single-use intermittent catheter. The known risks are like those of other intermittent catheters (listed in the section above). There is a small risk of allergic reaction or sensitivity to the catheter materials. If you have a history of having an allergy to catheter materials, you should not take part in this study.
Privacy and confidentiality risks
As with any research involving personal and health information, there is a small risk that your data could be seen by someone who is not authorized to see it. The study uses coding, secure systems, and restricted access to reduce this risk. These safeguards are described in more detail in the Confidentiality and HIPAA sections below.
Other risks
You may feel inconvenienced or fatigued by answering questionnaires. You may also feel uncomfortable answering some personal questions. You may skip any question you do not wish to answer.
NEW INFORMATION
You will be notified in a timely way if important new findings become known that may affect your willingness to continue in the study.
BENEFITS
We cannot promise that you will receive any direct benefit from participating in this study.
Some participants may find that they prefer GCAFW to their current catheter, but this cannot be guaranteed.
The information learned from this study may help improve future catheter designs, understand women’s experience with intermittent catheterization, and improve how direct-to-patient studies are conducted for people who rely on medical devices.
ALTERNATIVES TO STUDY PARTICIPATION
You do not have to take part in this study to receive treatment for your bladder condition. Alternatives include:
- continuing with your current catheter and usual care through 180 Medical or other suppliers
- discussing alternative catheter types or treatment options (including medications or procedures) with your healthcare provider
- choosing not to change anything at this time
Your healthcare provider can discuss the risks and benefits of these options with you.
COSTS OF PARTICIPATION
The sponsor (Convatec Inc) will provide the GCAFW catheters that will be used for the 14-day study period at no cost to you. The sponsor will also cover any costs directly related to the research procedures (for example, the electronic questionnaire platform).
You and/or your health insurance will continue to be responsible for the usual costs of your routine medical care and catheter supplies outside the 14-day study period. Taking part in this study is not expected to change your insurance coverage or your usual benefits, but you should contact your insurer if you have questions about coverage.
REIMBURSEMENT
To thank you for your time, you will receive a $50 electronic gift card after you complete the Day-14 follow-up questionnaire. Compensation is not tied to whether you continue using GCAFW after the study or how you answer any questions. It is simply to recognize your time and effort in completing the study questionnaires.
You will not receive payment for any products, tests, or potential commercial uses that may result from this research.
Tax law may require the payer (e.g., research institution or third party) to report the amount of payment you received from that payer to the Internal Revenue Service (IRS) or other agencies, as applicable. Generally, this reporting would take place if you received $600 or more from the payer in a calendar year. You would be responsible for paying the taxes on the payment you received from the study.
COMPENSATION FOR INJURY
For medical emergencies, call 911. If you become ill or are hurt while you are in this study, contact your study doctor immediately. The study doctor will assist you in obtaining appropriate medical treatment. The institution will not be responsible for the costs of treatment caused by the properly performed study procedures and/or study device.
The sponsor will pay for reasonable and necessary medical treatment of injuries and illness that are a direct result of study device and/or study procedures that are required by the study protocol and that were done correctly and only because you were in this study.
The sponsor will not cover the costs of your study-related injury or illness if:
- The sponsor and/or the study doctor do not think the condition or injury is a direct result of your being in the study
- The injury is attributable to the underlying disease or a pre-existing medical condition or the natural progression of an underlying disease
- The injury was the result of a failure to follow the study protocol or instructions or misconduct by the study staff.
No other compensation will be offered by the sponsor, 180 Medical or Biomedical Research Alliance of New York. This includes for things such as lost wages or discomfort. You are not waiving any legal right to seek additional compensation through the courts by signing this form.
VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is voluntary. You may decide not to participate, or you may stop your participation at any time without penalty, loss of benefits or medical care that you would otherwise receive. If you decide to leave the study, please tell the study doctor.
Your participation in this study may be stopped without your consent at any time and for any reason by the study doctor, the sponsor, the FDA and other regulatory authorities. Reasons you may be withdrawn from this study include if it is determined to be in your best interest, you need treatment not allowed in this study, you do not follow the study instructions, the study is stopped, or for other administrative reasons.
CONFIDENTIALITY
To the extent allowed by law, every effort will be made to keep your personal information confidential. However, information from this study will be submitted to the study sponsor and to the U.S. Food and Drug Administration. It may be submitted to governmental agencies in other countries where the study product may be considered for approval. Medical records, which identify you and the consent form signed by you, will be looked at by the sponsor or the sponsor’s representatives and may be looked at by the FDA and other regulatory agencies, the Institutional Review Board, and the Biomedical Research Alliance of New York. While these parties are aware of the need to keep your information confidential, total confidentiality cannot be guaranteed. The results of this research project may be presented at meetings or in publications; however, you will not be identified in these presentations and/ or publications.
If you take part in this study, you will be assigned a unique participant code to help protect your privacy. Your study records and study samples will be labeled with this code that does not directly identify you. The study site staff securely stores the linking code between your name and study information.
AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION
Federal regulations give you certain rights related to your health information. These include the right to know who will be able to get the information and why they may be able to get it. The study doctor must get your authorization (permission) to use or give out any health information that might identify you. If you choose to be in this study, the study doctor will get personal information about you. This may include information that might identify you. The study doctor may also get information about your health, including:
- Personal information, such as age, sex, race and ethnicity. This information helps the sponsor evaluate if the study product effects and the response to study product are different in different populations
- Past and present medical records
- Research records
- Records about phone calls made as part of this research
- Records about your study visits
- Information obtained during this research about laboratory test results
- Results from diagnostic and medical procedures including but not limited to X-rays, physical examinations and medical history
- Billing records
Information about your health may be used and given to others by the study doctor and staff. They might see the research information during and after the study. Your information may be given to the sponsor of this research. “Sponsor” includes any persons or companies that are working for or with the sponsor or are owned by the sponsor. Information about you and your health which might identify you may be given to:
- The U.S. Food and Drug Administration
- Department of Health and Human Services agencies
- Governmental agencies in other countries
- Biomedical Research Alliance of New York (BRANY)
- The Institutional Review Board
- Accrediting agencies
- Data safety monitoring boards
- Health insurers and payers
- Other individuals and organizations that analyze or use your information in connection with these research activities, including laboratories, contract research organization and study sites (if you transfer to another study site)
Your personal health information may be further shared by the groups above. If shared by them, the information will no longer be covered by the U.S. federal privacy laws. However, these groups are committed to keeping your personal health information confidential. If you give permission to give your identifiable health information to a person or business, the information may no longer be protected. There is a risk that your information will be released to others without your permission.
Information about you and your health that might identify you may be given to others to carry out the research study. The sponsor will analyze and evaluate the results of the study. In addition, people from the sponsor and its consultants will be visiting the research site. They will follow how the study is done, and they will be reviewing your information for this purpose. The information may be given to the FDA. It may also be given to governmental agencies in other countries. This is done so the sponsor can receive marketing approval for new products resulting from this research. The information may also be used to meet the reporting requirements of governmental agencies.
This authorization does not have an expiration date. If you do not withdraw this authorization in writing, it will remain in effect indefinitely.
By signing this consent form, you are giving permission to use and give out the health information listed above for the purposes described above. You do not have to sign this consent form. If you choose not to sign this consent form, you will not be able to be in this research study. Your decision not to sign this consent form will not have any effect on your medical care and you will not lose any benefits or legal rights to which you are entitled. You have the right to review, correct, and copy your health information. However, if you decide to be in this study and sign this permission form, you may not be allowed to look at or copy your information until after the research is completed.
You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor at the address on the front of this informed consent form. If you withdraw your permission, you will not be able to continue being in this study, but you will not have any penalty or loss of access to treatment or other benefits to which you are entitled. When you withdraw your permission, no new health information which might identify you will be gathered after that date. Information that has already been gathered may still be used and given to others. This would be done if it were necessary for the research to be reliable.
Your information collected as part of this research study, even if identifiers are removed, will not be used or distributed for future research studies.
Notice Concerning HIV-Related Information: HIV-related information that either is collected as part of the research or that may already exist in your medical record might be accessed for the research by the research staff and the study sponsor but will not be shared with others without your authorization, unless federal or state law requires the disclosure. You have a right to request a list of people who may receive or use your HIV-related information without authorization. If you experience discrimination because of the release or disclosure of HIV-related information, you may contact the agencies that are responsible for protecting your rights.
CONTACTS FOR QUESTIONS, COMPLAINTS, CONCERNS
If you have any questions or requests for information relating to this research study or your participation in it, or if you want to voice a complaint or concern about this research, or if you have a study related injury, you may contact Dr. Janet Kandrevas, MD at 405-267-8436.
If you seek emergency care or hospitalization, tell the treating health care providers that you are in this research study.
If you have any questions about your rights as a research participant or complaints regarding this research study, or you are unable to reach the research staff, you may contact a person independent of the research team at the Biomedical Research Alliance of New York Institutional Review Board at 516-318-6877. Questions, concerns or complaints about research can also be registered with the Biomedical Research Alliance of New York Institutional Review Board at www.branyirb.com/concerns-about-research. The IRB is a committee that reviews research studies to help protect the rights and welfare of study participants.