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

Ileostomy - Stoma Clinical Trial

— OUTFLOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06394115
• Other study ID #: OC-21-419
• Status: Completed
• Start date: August 1, 2022
• Est. completion date: June 19, 2023

Study information

• Verified date: April 2024
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 19, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colostomy Stoma
• Ileostomy - Stoma

Intervention

Device:
• Ostomy pouch
Ostomy pouch coated with novel technology

Locations

Country	Name	City	State
United States	Princeton Consumer Research	Raritan	New Jersey
United States	Princeton Consumer Research	Saint Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
ConvaTec Inc.	Princeton Consumer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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