Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2024-07-24
2024-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Leakage Detection System arm
Participants will utilize the leakage detection system
Ostomy Leakage Detection System
A system that is used to detect ostomy leaks
Interventions
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Ostomy Leakage Detection System
A system that is used to detect ostomy leaks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Hollister Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Mary Hugill
Role: PRINCIPAL_INVESTIGATOR
Dansac
Locations
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PPD Development, L.P.; Decentralized, Virtual Site; 11 Granta Park
Cambridge, Cambridgeshire, United Kingdom
Countries
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Other Identifiers
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6028-OST
Identifier Type: -
Identifier Source: org_study_id
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