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

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

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Device: Coloplast Test 1; Device: Coloplast Test 2

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713
    • QPS

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Leakage	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)	14 days

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Kalid S Abd-Elaziz, MD, QPS Holdings LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: October 1, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimate): November 26, 2013

Study Record Updates

• Last Update Posted (Estimate): April 7, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CP229