Evaluation of a New Supporting Ostomy Product | NCT04374890

Studies
Evaluation of a New Supporting Ostomy Product

NCT04374890

Sponsor

Coloplast A/S

Status

Unknown status

Last Update Posted

May 5, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Stoma Ileostomy

Interventions

CP308

Countries

Denmark

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2020Estimated

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Apr 29, 2020

First Submission Date that Met QC Criteria

May 1, 2020

First Posted Date

May 5, 2020Actual

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

May 1, 2020

Last Update Posted Date

May 5, 2020Actual

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 aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their ostomy appliance. Long-term benefits of the test product may be less skin redness, less worry of leakage and/or improvement in quality of life and social activities.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Experimental	Experimental		Device: CP308

Name	Type	Description	Arm Group Labels	Other Names
CP308	Device	3 weeks of baseline followed by 2x3 weeks use of the test device	Experimental

Measure	Description	Time Frame
Wear time	To evaluate the subject change pattern (wear time) when using the supporting product in 'real-life' situations'	9 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have given written informed consent
Be at least 18 years of age and have full legal capacity
Have had a stoma for more than three months
Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
Be able to use one of the three test products (i.e. Ø50, Ø60 and Ø70 mm)
Have an ileostomy- or colostomy with liq-uid output (Bristol scale type 6-7)
Currently using a SenSura Mio product (1pc/2pc Flat/Convex/Concave)
Be willing and suitable (determined by the study nurse) to use the test product with-out using a paste/mouldable ring during the test periods
Have self-reported problems with leakage* (three times within 14 days) *Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)

Exclusion Criteria:

Currently receiving or have within the past 2 month received radio- and/or chemotherapy
Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
Are pregnant or breastfeeding
Participating in other interventional clinical investigations or have previously participat-ed in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP308) protocol
Known sensitivity towards test product
Known sensitivity towards acrylate
Users with a pacemaker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Nov 15, 2022
Reset	Sep 27, 2023
Release	Oct 9, 2023
Reset	Apr 4, 2024
Release	Mar 7, 2025
Reset	Mar 27, 2025
Release	Aug 25, 2025
Reset	Sep 11, 2025

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 15, 2022			Sep 27, 2023
Oct 9, 2023