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

NCT06394115 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-05-01

No results posted yet for this study

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

Interventions

DEVICE

Ostomy pouch

Ostomy pouch coated with novel technology

Sponsors & Collaborators

  • Princeton Consumer Research

    collaborator OTHER

  • ConvaTec Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-03-30
Completion
2023-06-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06394115 on ClinicalTrials.gov