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

ConvaTec Inc.40 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Colostomy Stoma Ileostomy - Stoma

Interventions

Ostomy pouchDEVICE

Ostomy pouch coated with novel technology

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (2)

Princeton Consumer Research

St. Petersburg, Florida, United States

Princeton Consumer Research

Raritan, New Jersey, United States

Outcomes

Primary Outcomes

Performance of Convatec ostomy pouches which have the novel coating

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

Time frame: 16 days

Secondary Outcomes

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.

Time frame: 16 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.