Safety and Performance of New 1-piece Ostomy Product

Stoma Ileostomy Clinical Trial

Official title:

Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800916
• Other study ID #: CP236
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: October 31, 2014
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: April 2014
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

Description:

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have given written informed consent and signed letter of authority form.

2. Be at least 18 years of age and have full legal capacity.

3. Be able to handle the bags themselves.

4. Have an ileostomy with a diameter between 15 and 40 mm.

5. Have had their ostomy for at least three months.

6. Currently use a 1-piece flat ostomy appliance with open bag.

7. Use minimum 1 ostomy appliance every second day.

8. Be suitable for participation in the investigation and for using standard adhesive, flat base plate.

9. Must be able to use a custom cut ostomy appliance.

10. Accept to test three 1-piece ostomy appliances in the investigation.

11. Negative result of a pregnancy test for women of childbearing age (only DK).

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water).

2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.

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

4. Are pregnant or breastfeeding.

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

6. Currently using ostomy belt.

7. Currently using extended wear product.

8. Known hypersensitivity towards any of the test products

9. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse) -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stoma Ileostomy

Intervention

Device:
• Coloplast Adhesive baseplate A
Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
• Coloplast Adhesive baseplate B
Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
• Coloplast Adhesive baseplate C
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
• SenSura 1-Piece
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .

Locations

Country	Name	City	State
Denmark	Holtedam 3	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	Degree of Leakage	The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.; The subjects tick of one of the following choices: No leakage; Starting to leak; Leakage; Sudden Leakage	one week	Yes