Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

Ileostomy - Stoma Clinical Trial

Official title:

Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957397
• Other study ID #: CP230
• Status: Completed
• Phase: N/A
• First received: October 1, 2013
• Last updated: February 26, 2014
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: February 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

To investigate the performance and safety of the three 2-piece convex ostomy appliances

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects interested in participating in the clinical investigation must comply with the following criteria:

1. Are at least 18 years of age and have full legal capacity

2. Have had an ileostomy for at least 3 months.

3. Have used a convex ostomy appliance for the last month

4. Have given written informed consent

5. Have an ileostomy with a diameter of 33mm or less

6. Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion Criteria:

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)

2. Are pregnant* or breastfeeding.

3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.

4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.

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

6. Known hypersensitivity toward any of the test products

Study Design

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

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• Coloplast Test 1
Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
• Coloplast Test 2
Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
• Coloplast Test 3
Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance

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	Degree of Leakage	The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage uner baseplate)	14 days	No