Clinical trial NCT06547905: Evaluation of an Ostomy Leakage Detection System
Official title: Evaluation of an Ostomy Leakage Detection System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ostomy
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Accuracy of the Leakage Detection System (LDS)
timeFrame: through study completion, approximately 1 month
Secondary outcomes:
measure: How adherent subjects are to leakage notifications (ratio)
timeFrame: through study completion, approximately 1 month
measure: How efficacious leakage detection and notification was at alerting subjects to catastrophic leaks (ratio)
timeFrame: through study completion, approximately 1 month
measure: Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy leak Impact (OLI) validated tool
timeFrame: through study completion, approximately 1 month
measure: Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Ostomy Adjustment Inventory-23 (OA1-23) validated tool
timeFrame: through study completion, approximately 1 month
measure: Whether and to what extent the LDS affected Quality of Life (QoL), measured using the Single-item Sleep Quality Scale (SQS) validated tool
timeFrame: through study completion, approximately 1 month
Other outcomes:
measure: Whether and to what extent the LDS affected peristomal skin health, measured by the Ostomy Skin Tool 2.0 (OST 2.0) validated tool
timeFrame: starting at day 0, every 7 days, through day 28
measure: Whether and to what extent the LDS affected healthcare resource utilization (HRU) and cost-effectiveness
timeFrame: through study completion, approximately 1 month
measure: To evaluate how satisfied users were with the alerts/notifications from the LDS
timeFrame: through study completion, approximately 1 month
Locations:
city: Cambridge
country: United Kingdom
facility: PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park
state: Cambridgeshire
Study officials:
affiliation: Dansac
name: Mary Hugill
role: PRINCIPAL_INVESTIGATOR
References: