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Evaluation of an Ostomy Leakage Detection System

Study on Ostomy Leakage Detection System

Recruiting
18 years and older
All
Phase N/A

This study investigates an ostomy leakage detection system for individuals with an ostomy, which is a surgically created opening in the body for the discharge of body wastes. The purpose of this study is to evaluate the safety and effectiveness of this system in detecting leaks and notifying users. Participants will include those with ileostomy, colostomy, or urostomy, which are different types of ostomies based on the location and type of waste they discharge.

Participants will use their usual ostomy pouching system along with the study product. The study involves using a mobile application compatible with specific Android and Apple devices to monitor the leakage detection system. Participants will be required to download this application and provide feedback through electronic surveys. The study will help determine how well the leakage detection system works and whether it is safe for users.

  • Who can participate: Participants must be 18 years or older, residing in the United Kingdom, and have an ileostomy, colostomy, or urostomy. They should have a stoma diameter between 15 mm and 70 mm and a mild or moderate peristomal skin complication. Additionally, participants need to own a compatible smartphone and be willing to use the study product with their usual pouching system.
  • Study details: Participants will use their typical ostomy pouching system together with the study product. They will download and use a mobile application on their smartphone to interact with the leakage detection system. The study will involve providing feedback through electronic surveys.
Study details
    Ostomy

NCT06547905

Hollister Incorporated

2 December 2024

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