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
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
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.Summary of Results
Thank you to the individuals who participated in this important research.
Study Title: Evaluation of an Ostomy Leakage Detection System
Sponsor: Hollister Incorporated
Participants: 22 adults with an ostomy completed all or a portion of the evaluation.
Study Dates: July 26 – October 30 2024
Study Design & Location: Decentralized, at-home clinical investigation with participants from the United KingdomBackground and Purpose
People who live with an ostomy sometimes experience leakage from their pouching system, which can damage the skin around the stoma and affect quality of life.
This study tested a new Leakage Detection System (LDS) designed to give early warning when a leak may be starting, allowing people to change their barrier before a major leak occurs.
The purpose of the study was to understand how safe the system is to use at home and whether it can improve confidence and skin health for ostomy users.Who Took Part
A small group of adults living with an ostomy in the UK took part in the study.
All participants completed the 30-day period and provided information through electronic questionnaires about their experiences, device comfort, and any skin or technical issues.How the Study Was Conducted
Adults with an ostomy and mild or moderate peristomal skin irritation were invited to take part.
Participants used the LDS at home for about one month while continuing their normal pouching routine.
The system included a thin sensor disc worn under the barrier, a small wireless transmitter, and a smartphone app that alerted users if leakage was detected.
All study activities took place remotely in participants’ homes, and no medical procedures were required.Key Findings
• Safety: No serious medical problems related to the device occurred.
A few participants reported mild skin irritation where the device adhesive touched the skin.
• Performance: The device successfully detected some leaks early but also gave false alerts.
This limited users’ confidence in the system.
• User Experience: Most participants found the system easy to use and appreciated the idea of early leak warning.
Many said they felt slightly less anxious about leakage and noticed some improvement in the condition of the skin around the stoma.
• Technical Issues: Most commonly, issues related to Bluetooth connectivity of the System affected device performance and reliability.Overall Conclusions
The study showed that the leakage detection system can be used safely at home.
Although the device sometimes alerted users correctly, further development is needed to improve its accuracy and reliability before it can be widely adopted.
Participants’ feedback suggests that with technical improvements, the system may help people manage their ostomy more confidently and protect the skin around their stoma.Next Steps
The study results may be used to guide future technical improvements and plan future research.Compliance Statement:
This investigation was conducted in accordance with ISO 14155:2020, the UK Medical Devices Regulations 2002 (as amended), and ethical approval granted by a UK Research Ethics Committee.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