Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy

Stoma Ileostomy Clinical Trial

— CP257  

Official title:

Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887144
• Other study ID #: Coloplast - CP257
• Status: Completed
• Phase: N/A
• First received: December 17, 2015
• Last updated: August 29, 2016
• Start date: January 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.

Description:

Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• 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. Be able to handle the products themselves

4. Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm

5. Have had their ileostomy for at least 3 months

6. Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month

7. Currently using midi or maxi bags

8. Willing to use minimum 1 product every second day (max. 2 days wear time)

9. Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form

10. Must be able to cut products themselves

Exclusion Criteria:

1. Currently receiving or have received within the past 2 months chemo- or/and radiation therapy

2. Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area

3. Are pregnant or breastfeeding

4. Participating in other interventional clinical investigations or have previously participated in this investigation

5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).

6. Known hypersensitivity of the product components and/or ingredients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stoma Ileostomy

Intervention

Device:
• SenSura
SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S
• SenSura test product
SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S

Locations

Country	Name	City	State
Denmark	Coloplast A/S	Humlebaek

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of leakage	Leakage under and outside the baseplate will be assessed by a 4 point leakage scale.	patients will test the products for 4 weeks	No