Evaluation of an Ostomy Leakage Detection System

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

Study Overview

• Status: Completed
• Conditions: Ostomy
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB21 6GQ
      • PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leakage Detection System arm; Participants will utilize the leakage detection system	Device: Ostomy Leakage Detection System; A system that is used to detect ostomy leaks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
How adherent subjects are to leakage notifications (ratio)	The proportion of barriers that are changed due to accurate leakage notifications will yield insights into how adherent subjects are to leakage notifications.	through study completion, approximately 1 month
How efficacious leakage detection and notification was at alerting subjects to catastrophic leaks (ratio)	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	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	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	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	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	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	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	through study completion, approximately 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whether and to what extent the LDS affected peristomal skin health, measured by the Ostomy Skin Tool 2.0 (OST 2.0) validated tool	The Ostomy Skin Tool 2.0 (OST 2.0) validated tool will be used to evaluate and compare skin health before subjects use the LDS at the Day 0 Periodic assessment and every 7 days thereafter up to Day 28. The OST 2.0 is scored on a scale of 0-3 with higher scores indicating worse outcomes.	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	Ostomy accessory usage, unplanned ostomy-related healthcare visits to a provider (such as a nurse or doctor, for example), incidence of and severity of PSCs (which have been shown to be associated with increased HRU), and/or wear (use) time of the ostomy barrier will be measured at periodic timepoints in the study (days 0, 7, 14, 21, 28, and/or 30) to obtain healthcare resource utilization (or cost) data which will be aggregated (summed) to evaluate the effect the LDS has on HRU and cost-effectiveness.	through study completion, approximately 1 month
To evaluate how satisfied users were with the alerts/notifications from the LDS	Satisfaction scores will be reported as the proportion of each response option on a 5-point scale, from very unsatisfied to very satisfied.	through study completion, approximately 1 month

Collaborators and Investigators

• Sponsor: Hollister Incorporated
• Investigators: Principal Investigator: Mary Hugill, Dansac

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 6028-OST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No