NCT06914804

Stomasense: A New Route to the Proactive Detection and Management of Leaks Within Ostomy Pouches

StatusCompleted

PhaseNot applicable

SponsorUniversity of Ulster

Primary completionJan 3, 2026

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 10, 2026 Eligibility criteria expanded, about 17 words Show 6 more changesShow less
- Trial status changed: Enrolling by Invitation → Completed
- Final enrollment: 50 participants (planned 100)
- Primary and study completion dates changed from estimate of Jan 31, 2026 to Jan 3, 2026
- Start date changed from estimate of Apr 14, 2025 to Apr 30, 2025
- Secondary endpoints: details revised at 1 of 4 entries
- Study description expanded, about 4 words
Apr 2, 2025 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Psychiatric morbidity

Timeframe: Comparison between treatments over a 2-week period.

Psychological well-being

Timeframe: Comparison between treatments over a 2-week period.

General quality of life

Timeframe: Comparison between treatments over a 2-week period.

Stress and coping

Timeframe: Change over 2 weeks comparison between treatments

Resillience

Timeframe: Change over 2 weeks comparison between treatments

Stoma related quality of life

Timeframe: Comparison between treatments over a 2-week period.

Secondary (4)

Device accuracy

Device usability

Dietary intake

Peristomal skin condition

Arms and interventions

Leak detection device (microbutton probes)Experimental

Leakage events will be detected by microbutton probes, which are attached to the sensing device

Leak detection device (microwire probes)Experimental

Leakage events will be detected by microwire probes, which are attached to the sensing device

Devices: Stomasense

Sites

1 site in 1 country

Ulster University, Human Intervention Studies UnitColeraine, Co. Derry, United Kingdom

About this trial

People living with an ileostomy may often experience leaks from their stoma pouches. Leakages are a highly stressful experience, so it is no surprise that worry about leaks is very common among ileostomates and this can contribute to increased anxiety and impact negatively on quality of life. Ileostomates will make changes to their lifestyle to minimise the occurrence of leaks; they may avoid travelling long distances, steer clear of busy social events and often restrict certain food(s) and / or drink(s). The latter stands in the way of achieving a healthy balanced diet and can put ileostomates at risk of developing nutritional deficiencies. Researchers at ulster university have developed a leak sensor device which can be worn unobtrusively alongside any stoma pouch. The device can detect the early stages of a leak from the stoma bag and alerts the user, meaning they are able to change their pouch before it's too late. Participants will be asked to trial 2 versions of the device, each over a 2-week period. At the beginning and end of each period participants will complete a series of questionnaires to allow the research team to determine device efficacy and impact on quality of life. Food diaries will also be completed by participants to give an indication of how dietary intake can impact the incidence of pouch leakage.

Trial details

Enrollment: 50 participants (actual)
Started: Apr 30, 2025
Study completion: Jan 3, 2026
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, triple blind, prevention
Oversight: No data monitoring committee
Conditions: Ileostomy - Stoma
First posted: Apr 6, 2025
Registry updated: Nov 12, 2026
Last verified: Nov 2026

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