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

NCT06914804 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Ileostomy - Stoma

Interventions

DEVICE

Stomasense

A smart device worn alongside stoma pouch systems which detects onset of a leak.

Sponsors & Collaborators

  • University of Ulster

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-14
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06914804 on ClinicalTrials.gov