Evaluation of an Ostomy Leakage Detection System

Not Applicable

Completed

• Conditions: Ostomy
• Interventions: Device: Ostomy Leakage Detection System

• Registration Number: NCT06547905
• Lead Sponsor: Hollister Incorporated

Brief Summary

This study will evaluate the safety and efficacy of an ostomy leakage detection system.

Detailed Description

Individuals with an ostomy will be recruited to evaluate an ostomy leakage detection system. The ostomy leakage detection system is designed to detect leaks and notify users of the leaks. Participants will evaluate the safety and efficacy of the leakage detection system.

Study Timeline

• Study First Submitted: 2024-06-14
• Study Start: 2024-07-24
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-09
• Primary Completion: 2024-10-30
• Study Completion: 2024-11-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. 18 years or Older

2. Currently resides in the United Kingdom

3. Has an ileostomy, colostomy, or urostomy

4. Has a stoma diameter within the following range: 15 mm - 70 mm

5. Has a mild or moderate peristomal skin complication as defined using the Ostomy Skin Tool (OST) 2.0 (decision tree (DT)=1 or DT=2).

6. Has experienced a leak underneath or outside the perimeter of the barrier in the last 30 days or has worried about leakage in the last 30 days

7. Willing to use their typical ostomy pouching system together with the study product for duration of study

8. Currently has an Android Smart phone or an Apple iPhone of the following operating systems (OS):

   • a. Android Devices:

     • i. Compatible Brands: Samsung Galaxy, Huawei, Google Pixel
     • ii. Operating System: Android OS 9.0 (Pie) and later

   • b. Apple iPhones:

     • i. Compatible Models: iPhone X and later
     • ii. Operating System: iPhone Operating System (iOS) 15 and newer

9. Is willing to download the phone application for use during the study

10. Is willing to follow protocol procedures, as indicated by signing the informed consent

11. Is able to receive, read, and respond to English surveys electronically (i.e. via a computer or smart phone)

Exclusion Criteria

1. Subject reports changing their ostomy barrier 3 or more times per day in the last 30 days
2. Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or body worn medical device (e.g. insulin pump)
3. Subject reports that a caregiver, or someone other than themselves, is solely responsible for changing their ostomy pouching system. Note: subjects that use a combination of self-care and other assistance should not be excluded.
4. Reports as legally blind and/or deaf
5. Subject does not report a peristomal skin complication (PSC) or the subject reports a PSC that is scored as severe on the OST 2.0 tool (either a DT=0 or DT=3).
6. Subject reports currently having an abdominal fistula or abdominal wound
7. Subject has more than one stoma
8. Is undergoing chemotherapy, radiation, or non-inhaled steroid therapy (topical/applied to the skin around the stoma) that may compromise the skin
9. Is pregnant or breastfeeding at time of eligibility, as determined by self-report. Note: this exclusion will not be re-confirmed throughout the study after eligibility.
10. Is currently involved in another research study involving use of ostomy study products or accessories
11. Is currently an employee of a Company that manufactures Ostomy Products and/or Ostomy Accessories

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leakage Detection System arm	Ostomy Leakage Detection System	Participants will utilize the leakage detection system

Primary Outcome Measures

Name	Time	Method
The Accuracy of the Leakage Detection System (LDS)	through study completion, approximately 1 month	The frequency of true positive, true negative, false positive, and false negative leakage detection events will be used to quantify the accuracy of the leakage detection system.

Secondary Outcome Measures

Name	Time	Method
How efficacious leakage detection and notification was at alerting subjects to catastrophic leaks (ratio)	through study completion, approximately 1 month	The ratio of the number of times subjects were alerted to leakage prior to a CL occurring to the number of times a barrier change was associated with a Catastrophic leak
Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Single-item Sleep Quality Scale (SQS) validated tool	through study completion, approximately 1 month	QoL will be measured at baseline and after approximately 1 month to determine whether the LDS affected QoL and to what extent using the SQS which is scored on a scale of 0-10 with higher scores indicating better outcomes
How adherent subjects are to leakage notifications (ratio)	through study completion, approximately 1 month	The proportion of barriers that are changed due to accurate leakage notifications will yield insights into how adherent subjects are to leakage notifications.
Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy leak Impact (OLI) validated tool	through study completion, approximately 1 month	QoL will be measured at baseline and after approximately 1 month to determine whether the LDS affected QoL and to what extent using the OLI which is scored on a scale of 0-100 with higher scores indicating better outcomes
Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy Adjustment Inventory-23 (OA1-23) validated tool	through study completion, approximately 1 month	QoL will be measured at baseline and after approximately 1 month to determine whether the LDS affected QoL and to what extent using the OAI-23 which is scored on a scale of 0-92 with higher scores indicating better outcomes

Trial Locations

Locations (1)

PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom