6028-OST Evaluation of an Ostomy Leakage Detection System
Research type
Research Study
Full title
Evaluation of an Ostomy Leakage Detection System
IRAS ID
336495
Contact name
Mary Hugill
Contact email
Sponsor organisation
Hollister Incorporated
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
This clinical investigation is for a leakage detection system (Reassurance system) which is an accessory that detects leaks underneath an ostomy barrier before users may become aware of a leak.
Catastrophic leakage prevention is a foundational need. Potential causes of leakage include lack of proper fit, skin irritation preventing adhesion, warm weather/perspiration during exercise, high output exceeding pouch capacity, end-user error or lack of dexterity. While most users are able to resolve ongoing leakage problems, one experience can be enough to cause fear of future leaks.
In two previous studies, 6004—OST, evaluated two prototype devices to determine if they detected ostomy leakage and if one was more effective. 6019-OST evaluated the leakage detection functionality and the entire Reassurance ecosystem. A recent study in the UK and Germany, found 59% of surveyed ostomates experienced leaks at least once a month and 74% agreed that more frequent leaks negatively affect skin health (Hollister Incorporated, 2023).
The primary purpose of this study is to assess the safety and efficacy of the Reassurance System, by evaluating the adverse events and device deficiencies, and the leakage detection accuracy, sensitivity, specificity, and precision.
This study will include a single remote site using an at-home decentralized trial format. All activities will be performed by the participant at their home. 40 participants will receive product shipment with a minimum of 25 subjects to complete the full 30-day study and final evaluation.
Participants will be asked to complete a daily check-in questionnaire to monitor their product wears, quality, and any changes in their overall health, also complete periodic questionnaires throughout the 30-day evaluation period on days 1, 7, 14, 21, and 28. Final evaluation will take place on day 30. Participation will end once the participant finishes the Day 30 final evaluation form.
This study is sponsored by Hollister Incorporated.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
24/WM/0037
Date of REC Opinion
2 Apr 2024
REC opinion
Further Information Favourable Opinion