Ileostomy - Stoma Clinical Trial
— OUTFLOWOfficial title:
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
NCT number | NCT06394115 |
Other study ID # | OC-21-419 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2022 |
Est. completion date | June 19, 2023 |
Verified date | April 2024 |
Source | ConvaTec Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 19, 2023 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - • Subjects with a colostomy or ileostomy - Age 18 years and over - Medically stable in the opinion of the investigator - Are able and willing to provide informed consent - Are able and willing to attend study visits - Currently use the same models of pouches as required by the study - Have a recent history of frequent pancaking (colostomy patients only) - Willing to stop using any lubricants in the pouches whilst participating in the study. - Subject has a valid email address for the Investigator to send links to study questionnaires and has access to a web enabled device. Exclusion Criteria: - • Subjects with any peristomal skin condition classified as non-intact skin at the time of enrolment - Subjects who maybe receiving any concomitant treatment and/or medications which could impact the consistency of effluent during the study period. - Allergic to any components of the Novel Lubricant inclusive of Soyabean and/or Vitamin E. |
Country | Name | City | State |
---|---|---|---|
United States | Princeton Consumer Research | Raritan | New Jersey |
United States | Princeton Consumer Research | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
ConvaTec Inc. | Princeton Consumer Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance of Convatec ostomy pouches which have the novel coating | To demonstrate the performance of Convatec ostomy pouches which have the novel coating | 16 days | |
Secondary | to investigate the safety of Convatec Ostomy Pouches modified with a novel coating | Evaluation of device related safety events during the treatment period and Evaluation of quality of life and patient perception of product. | 16 days |
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