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Sponsor decided to terminate study due to insufficient recruitment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OstoRing® | Device | Participants will use the OstoRing® along with their standard pouching equipment. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene F Yen, MD, MBA | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem Evanston Hospital | Evanston | Illinois | 60201 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2019 | Feb 19, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2021 | Mar 18, 2022 | ICF_000.pdf |
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Early feasibility device study
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| 75 days |