Evaluation of a New Supporting Ostomy Product

Stoma Ileostomy Clinical Trial

Official title:

Evaluation of a New Supporting Ostomy Product

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04374890
• Other study ID #: CP308
• Status: Recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Coloplast A/S
• Contact: Thomas Krarup Simonsen
• Phone: +45 4911 1873
• Email: clinical-studies[@]coloplast.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stoma Ileostomy

Intervention

Device:
• CP308
3 weeks of baseline followed by 2x3 weeks use of the test device

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebæk

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

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