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

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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:
Information provided by (Responsible Party):
Coloplast A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Ileostomy - Stoma
Interventions Device: Coloplast Test 1
Device: Coloplast Test 2
Enrollment 18
Recruitment Details The subject were recruited through the Coloplast database in The Netherlands
Pre-assignment Details  
Arm/Group Title First Coloplast Test 1, Then Coloplast Test 2 First Coloplast Test 2, Then Coloplast Test 1
Hide Arm/Group Description

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

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

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

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

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

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

Period Title: Baseline - Own Product
Started 9 9
Completed 9 9
Not Completed 0 0
Period Title: Test Period 1
Started 9 9
Completed 9 7
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Adverse Event             0             1
Period Title: Test Period 2
Started 9 7
Completed 8 6
Not Completed 1 1
Reason Not Completed
Adverse Event             1             0
Protocol Violation             0             1
Arm/Group Title Overall Study
Hide Arm/Group Description All the subjects in one group
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
54.4  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
10
  55.6%
Male
8
  44.4%
1.Primary Outcome
Title Degree of Leakage
Hide Description 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)
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coloplast Test 1 Coloplast Test 2 Basline - Own Product
Hide Arm/Group Description:
Results from subjects testing Coloplast Test 1
Results from subjects testing Coloplast Test 2
Data from subject testing own product. Measures baseline leakage
Overall Number of Participants Analyzed 16 18 18
Overall Number of Units Analyzed
Type of Units Analyzed: Baseplates
229 208 267
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.9  (4.2) 2.5  (4.3) 3.1  (5.7)
Time Frame September - November 2012
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coloplast Test 1 Coloplast Test 2 Basline - Own Product
Hide Arm/Group Description Results from subjects testing Coloplast Test 1 Results from subjects testing Coloplast Test 2 Data from subject testing own product. Measures baseline leakage
All-Cause Mortality
Coloplast Test 1 Coloplast Test 2 Basline - Own Product
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Coloplast Test 1 Coloplast Test 2 Basline - Own Product
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coloplast Test 1 Coloplast Test 2 Basline - Own Product
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/16 (18.75%)      1/18 (5.56%)      0/18 (0.00%)    
Gastrointestinal disorders       
Diarrhoea *  0/16 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Skin and subcutaneous tissue disorders       
Redness skin *  2/16 (12.50%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0
Peristomal skin irritaion *  1/16 (6.25%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Affairs
Organization: Coloplast A/S
Phone: +45 4911 25 23
EMail: dkdac@coloplast.com
Layout table for additonal information
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01994876    
Other Study ID Numbers: CP229
First Submitted: October 1, 2013
First Posted: November 26, 2013
Results First Submitted: February 26, 2014
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014