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

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma; Colostomy Stoma
• Intervention / Treatment: Device: Ostomy pouch

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33702
      • Princeton Consumer Research
  • New Jersey
    • Raritan, New Jersey, United States, 08869
      • Princeton Consumer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A minimum of 15 colostomy and minimum of 10 ileostomies

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Collaborators: Princeton Consumer Research

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): June 19, 2023

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Colostomy; Ileostomy
• Other Study ID Numbers: OC-21-419

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No