Evaluation of an Ostomy Leakage Detection System

NCT06547905 | Completed

• 1 other identifier: 6028-OST
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ostomy

Outcome Measures

Primary Outcomes (1)

• The Accuracy of the Leakage Detection System (LDS)

  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.

  through study completion, approximately 1 month

Secondary Outcomes (5)

• How adherent subjects are to leakage notifications (ratio)

  through study completion, approximately 1 month

• How efficacious leakage detection and notification was at alerting subjects to catastrophic leaks (ratio)

  through study completion, approximately 1 month

• 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

• 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

• 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

Other Outcomes (3)

• Whether and to what extent the LDS affected peristomal skin health, measured by the Ostomy Skin Tool 2.0 (OST 2.0) validated tool

  starting at day 0, every 7 days, through day 28

• Whether and to what extent the LDS affected healthcare resource utilization (HRU) and cost-effectiveness

  through study completion, approximately 1 month

• To evaluate how satisfied users were with the alerts/notifications from the LDS

  through study completion, approximately 1 month

Study Arms (1)

Leakage Detection System arm

EXPERIMENTAL

Participants will utilize the leakage detection system

Device: Ostomy Leakage Detection System

Interventions

Ostomy Leakage Detection System DEVICE

A system that is used to detect ostomy leaks

Leakage Detection System arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or Older
• Currently resides in the United Kingdom
• Has an ileostomy, colostomy, or urostomy
• Has a stoma diameter within the following range: 15 mm - 70 mm
• 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).
• 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
• Willing to use their typical ostomy pouching system together with the study product for duration of study
• 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
• Is willing to download the phone application for use during the study

You may not qualify if:

• Subject reports changing their ostomy barrier 3 or more times per day in the last 30 days
• Has an electrical implant (e.g. pacemaker or internal defibrillator) and/or body worn medical device (e.g. insulin pump)
• 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.
• Reports as legally blind and/or deaf
• 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).
• Subject reports currently having an abdominal fistula or abdominal wound
• Subject has more than one stoma
• Is undergoing chemotherapy, radiation, or non-inhaled steroid therapy (topical/applied to the skin around the stoma) that may compromise the skin
• Is currently involved in another research study involving use of ostomy study products or accessories
• Is currently an employee of a Company that manufactures Ostomy Products and/or Ostomy Accessories

Sponsors & Collaborators

• Hollister Incorporated: lead

Study Sites (1)

PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park

Cambridge, Cambridgeshire, CB21 6GQ, United Kingdom

Location

Study Officials

• Mary Hugill

  Dansac

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: August 9, 2024
• Study Start: July 24, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 15, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)