Study of TRE Seals on Early Post-operative Subjects (NCT07460323) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of TRE Seals on Early Post-operative Subjects
107 participantsStarted 2026-06
Plain-language summary
This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 18 years of age
. Has their ostomy surgery and post-operative care in the United Kingdom (UK)
. Has a colostomy, ileostomy, or urostomy and no reversal planned during the study evaluation period
. Able to have first study product applied at first pouch change after surgery (or up to 4 days post-op)
. Is appropriate to use a barrier seal per the Investigator
. Able to provide an informed consent for study participation
. Willing to follow protocol procedures, including participating in study visits, as demonstrated by signing the informed consent
Exclusion criteria
. Is over 85 years of age
. Has received chemotherapy or radiation in the past 30 days or reports beginning chemotherapy or radiation during the study.
. A score of 1, 2, or 3 for any of the three OCSI Tool PSC-related domains (i.e., peristomal irritant dermatitis, peristomal bleeding, and hyperplasia) at time of enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI)
Timeframe: From enrollment to the end of treatment at 9 weeks