Evaluation of a New Supporting Ostomy Product

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.

Study Overview

• Status: Unknown
• Conditions: Stoma Ileostomy
• Intervention / Treatment: Device: CP308

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Recruiting
    • Coloplast A/S
    • Contact: Thomas Krarup Simonsen; Phone Number: +45 49111111; Email: clinical-studies@coloplast.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than three months
4. Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
5. Be able to use one of the three test products (i.e. Ø50, Ø60 and Ø70 mm)
6. Have an ileostomy- or colostomy with liq-uid output (Bristol scale type 6-7)
7. Currently using a SenSura Mio product (1pc/2pc Flat/Convex/Concave)
8. 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
9. 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:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
3. Are pregnant or breastfeeding
4. 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
5. Known sensitivity towards test product
6. Known sensitivity towards acrylate
7. Users with a pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Device: CP308; 3 weeks of baseline followed by 2x3 weeks use of the test device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CP308

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No