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ENROLLING BY INVITATION
NCT06914804
NA

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

Sponsor: University of Ulster

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-04-14

Completion Date

2026-01-31

Last Updated

2025-04-06

Healthy Volunteers

No

Interventions

DEVICE

Stomasense

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

Locations (1)

Ulster University, Human Intervention Studies Unit

Coleraine, Co. Derry, United Kingdom