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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2024
Source ConvaTec Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ostomy pouch
Ostomy pouch coated with novel technology

Locations

Country Name City State
United States Princeton Consumer Research Raritan New Jersey
United States Princeton Consumer Research Saint Petersburg Florida

Sponsors (2)

Lead Sponsor Collaborator
ConvaTec Inc. Princeton Consumer Research

Country where clinical trial is conducted

United States, 

Outcome

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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