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

Completed

• Conditions: Ileostomy - Stoma; Colostomy Stoma

• Registration Number: NCT06394115
• Lead Sponsor: ConvaTec Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-22
• Study Start: 2022-08-01
• Primary Completion: 2023-03-30
• Study Completion: 2023-06-19
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-27
• Last Update Submitted: 2024-04-27
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of Convatec ostomy pouches which have the novel coating	16 days	To demonstrate the performance of Convatec ostomy pouches which have the novel coating

Secondary Outcome Measures

Name	Time	Method
to investigate the safety of Convatec Ostomy Pouches modified with a novel coating	16 days	Evaluation of device related safety events during the treatment period and Evaluation of quality of life and patient perception of product.

Trial Locations

Locations (1)

Princeton Consumer Research; 🇺🇸 Raritan, New Jersey, United States