Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy

• ClinicalTrials.gov Identifier: NCT01994876
• Recruitment Status: Completed
• First Posted: November 26, 2013
• Results First Posted: April 7, 2014
• Last Update Posted: April 7, 2014
• Sponsor: Coloplast A/S
• Information provided by (Responsible Party): Coloplast A/S

Study Description

Brief Summary:

To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances

Condition or disease	Intervention/treatment	Phase
Ileostomy - Stoma	Device: Coloplast Test 1; Device: Coloplast Test 2	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
• Study Start Date: September 2012
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: November 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: First Coloplast Test 1; The subjects first test their own product to collect a baseline measurement The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2	Device: Coloplast Test 1; Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance; Device: Coloplast Test 2; Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance
Experimental: First Coloplast Test 2; The subjects first test their own product to collect baseline measurements The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1	Device: Coloplast Test 1; Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance; Device: Coloplast Test 2; Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance

Outcome Measures

Primary Outcome Measures :

1. Degree of Leakage [ Time Frame: 14 days ]
   The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Subjects must comply with the following criteria in order to participate in the investigation:

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 33 mm or less
6. Have experience 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 (adreno-cortical hormone) in the peristomal area
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
6. Are currently participating in another clinical investigation or has previously participated in this investigation

Contacts and Locations

Locations

Netherlands

QPS

Groningen, Netherlands, 9713

Sponsors and Collaborators

Coloplast A/S

Investigators

• Principal Investigator: Kalid S Abd-Elaziz, MD; QPS

More Information

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT01994876
• Other Study ID Numbers: CP229
• First Posted: November 26, 2013
• Results First Posted: April 7, 2014
• Last Update Posted: April 7, 2014
• Last Verified: February 2014