Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management (NCT04802538) | Clinical Trial Compass
TerminatedNot Applicable
Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management
Stopped: Sponsor decided to terminate study due to insufficient recruitment.
United States3 participantsStarted 2020-11-06
Plain-language summary
In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 (OstoRingĀ® 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 ā„3