Evaluation of a New Supporting Ostomy Product

NCT ID: NCT04374890

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2020-12-31

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.

Conditions

Stoma Ileostomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental

Group Type: EXPERIMENTAL

CP308

Intervention Type: DEVICE

3 weeks of baseline followed by 2x3 weeks use of the test device

Interventions

CP308

3 weeks of baseline followed by 2x3 weeks use of the test device

Intervention Type: DEVICE

Eligibility Criteria

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

5. Known sensitivity towards test product

6. Known sensitivity towards acrylate

7. Users with a pacemaker

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Coloplast A/S

Humlebæk, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Thomas Krarup Simonsen

Role: CONTACT

clinical-studies@coloplast.com

+45 4911 1873

Facility Contacts

Thomas Krarup Simonsen

Role: primary

clinical-studies@coloplast.com

+45 49111111

Other Identifiers

CP308

Identifier Type: -

Identifier Source: org_study_id