Status:
TERMINATED
Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management
Lead Sponsor:
Endeavor Health
Conditions:
Stoma Site Leakage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.
Detailed Description
In this crossover design trial, patients will be asked to first wear their normal ostomy pouching equipment for 28 days followed by 28 days with the OstoRing®. Patients may choose to continue using th...
Eligibility Criteria
Inclusion
- Are at least 18 years of age and have full legal capacity
- Have had an end or loop ileostomy or colostomy for at least 6 months.
- Have used a Hollister 2 piece New Image pouching system for at least 8 weeks
- Able to provide informed consent
- Have a stoma with a diameter of 57mm or less
- Change their pouching system at least two times in seven days
Exclusion
- Unable to give informed consent.
- Are pregnant or currently breastfeeding.
- In the last 2 months has received or is currently receiving, chemotherapy or radiation therapy.
- In the last month has received or is currently receiving systemic or local steroid treatment in the peristomal area.
- Currently suffering from severe peristomal skin problems such as peristomal pyoderma, abscess.
- Currently suffering from a peristomal hernia.
- Known hypersensitivity toward any of the test product (OstoRing® is made of surgical grade stainless steel)
- In the last 30 days has participated or is currently participating in a clinical study
- Assessed with an ostomy skin tool score of ≥3
Key Trial Info
Start Date :
November 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04802538
Start Date
November 6 2020
End Date
August 4 2021
Last Update
April 24 2024
Active Locations (1)
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1
NorthShore University HealthSystem Evanston Hospital
Evanston, Illinois, United States, 60201