Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study

NCT06394115 | Completed

• 1 other identifier: OC-21-419
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colostomy Stoma; Ileostomy - Stoma

Keywords

Ileostomy; Colostomy; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to investigate the safety of Convatec Ostomy Pouches modified with a novel coating

  16 days

Interventions

Ostomy pouch DEVICE

Ostomy pouch coated with novel technology

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A minimum of 15 colostomy and minimum of 10 ileostomies

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ConvaTec Inc.: lead
• Princeton Consumer Research: collaborator

Study Sites (2)

Princeton Consumer Research

St. Petersburg, Florida, 33702, United States

Location

Princeton Consumer Research

Raritan, New Jersey, 08869, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: May 1, 2024
• Study Start: August 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: June 19, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)