Performance and Safety of a Novel Ostomy Ring to Improve Ileostomy and Colostomy Management

Study Overview
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Brief Summary
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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
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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 the OstoRing for an additional 19 days. Study visits will occur between each section of the trial and will involve a skin assessment and quality of life questionnaires. Additionally, over the course of the trial, participants will be asked to fill out a survey and take a picture of their stoma with ostomy pouching change.

Official Title
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A Phase 1 Clinical Trial to Assess the Performance and Safety of a Novel Ostomy Ring (OstoRing®) to Improve Ileostomy and Colostomy Management

Conditions
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Stoma Site Leakage

Intervention / Treatment
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* Device: OstoRing®


Participation Criteria
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Eligibility Criteria
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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 (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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Early feasibility device study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>All patients will begin the study by using their normal ostomy pouching equipment for 28 days. This will be followed by a transition to using the OstoRing® for 28-47 days. | Device: OstoRing®<br>* Participants will use the OstoRing® along with their standard pouching equipment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pouching Equipment Wear Time/Lifespan | Mean pouching system wear time will be calculated with and without the OstoRing®. | 75 days | 
| Coloplast Tool Skin Assessment Score | The skin surrounding the peristomal area will be assessed at all study visits utilizing the coloplast skin score tool. Skin score may range from 0 to 15 with a smaller score indicating better skin condition in the peristomal area. | 75 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| City of Hope Quality of Life Ostomy Questionnaire Score | Quality of life will be assessed at all study visits utilizing the City of Hope Quality of Life Ostomy Questionnaire. This instrument contains 43 questions with answers on a Likert scale from 1 to 10. The final score is the sum of all responses divided by the total number questions which gives a final score from 1 to 10. Greater score on this survey is indicative of a better quality of life. | 75 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileostomy, colostomy, stoma