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OpenTrials
Completed

NCT Number: NCT06394115

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

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.

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Key information

Conditions

Colostomy Stoma Ileostomy - Stoma

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Princeton Consumer Research, St. Petersburg, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ostomy pouch

Device

Ostomy pouch coated with novel technology

Primary outcomes

  1. Performance of Convatec ostomy pouches which have the novel coating

    Time frame: 16 days

    To demonstrate the performance of Convatec ostomy pouches which have the novel coating

Secondary outcomes

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

    Time frame: 16 days

    Evaluation of device related safety events during the treatment period and Evaluation of quality of life and patient perception of product.

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Collaborators

  • Princeton Consumer Research

Registry information

Acronym: OUTFLOW

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 1, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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