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

NCT01957397 | Completed Results

• 1 other identifier: CP230
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• 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 under the baseplate)

  14 days

Study Arms (2)

Coloplast Test 1

EXPERIMENTAL

The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2 Finally the all subject test Coloplast Test 3

Device: Coloplast Test 1; Device: Coloplast Test 2; Device: Coloplast Test 3

Coloplast Test 2

EXPERIMENTAL

The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1 Finally the all subject test Coloplast Test 3

Device: Coloplast Test 1; Device: Coloplast Test 2; Device: Coloplast Test 3

Interventions

Coloplast Test 1 DEVICE

Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance

Coloplast Test 1; Coloplast Test 2

Coloplast Test 2 DEVICE

Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance

Coloplast Test 1; Coloplast Test 2

Coloplast Test 3 DEVICE

Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance

Coloplast Test 1; Coloplast Test 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects interested in participating in the clinical investigation must comply with the following criteria:
• Are at least 18 years of age and have full legal capacity
• Have had an ileostomy for at least 3 months.
• Have used a convex ostomy appliance for the last month
• Have given written informed consent
• Have an ileostomy with a diameter of 33mm or less
• Have experienced leakage (seeping) under the baseplate at least two times over the last two weeks

You may not qualify if:

• Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
• Have a loop ostomy (also called double-barrel or ostomy with two outlets)
• Are pregnant\* or breastfeeding.
• Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
• Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.
• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).
• Known hypersensitivity toward any of the test products

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Results Point of Contact

• Title: Birte Petersen Jakobsen, MD
• Organization: Coloplast A/S

dkbir@coloplast.com

+45 4911 1395

Study Officials

• Birte P Jakobsen, MD

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 30, 2016
• Results First Posted: April 7, 2014

Record last verified: 2016-08

Locations

DK (1)