Assessment of Novel Technology to Facilitate Drainage in... | NCT06394115

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

NCT06394115

Sponsor

ConvaTec Inc.

Status

Completed

Last Update Posted

May 1, 2024Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Colostomy Stoma
Ileostomy - Stoma

Interventions

Ostomy pouch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Actual

Primary Completion Date

Mar 30, 2023Actual

Completion Date

Jun 19, 2023Actual

First Submitted Date

Jul 22, 2022

First Submission Date that Met QC Criteria

Apr 27, 2024

First Posted Date

May 1, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2024

Last Update Posted Date

May 1, 2024Actual

Name	Class
Princeton Consumer Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
Ostomy pouch	Device	Ostomy pouch coated with novel technology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

A minimum of 15 colostomy and minimum of 10 ileostomies

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princeton Consumer Research		St. Petersburg	Florida	33702	United States
Princeton Consumer Research

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided