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Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

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ClinicalTrials.gov Identifier: NCT01994863
Recruitment Status : Terminated (Problems with product performance)
First Posted : November 26, 2013
Results First Posted : March 11, 2015
Last Update Posted : March 11, 2015
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: Prevention
Condition Ileostomy - Stoma
Interventions Device: Coloplast Test product
Device: Standard Care
Enrollment 23
Recruitment Details  
Pre-assignment Details "Not completed" includes those who did not complete the entire period (those that did not try all products within the period) and then continued to next period, if relevant.
Arm/Group Title First Coloplast Test Product; Then Standard Care (See Below) First Standard Care (See Below); Then Coloplast Test Product
Hide Arm/Group Description

The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.

Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.

The three Standard Care products were tested in a 1:1:1 randomisation.

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

Standard Care: Standard care consists of three already marketed 1-piece ostomy products

Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima

The subjects are randomised to test Standard care first and thereafter test Coloplast test product.

Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.

The three Standard Care products were tested in a 1:1:1 randomisation.

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

Standard Care: Standard care consists of three already marketed 1-piece ostomy products

Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima

Period Title: Period 1
Started 11 12
Completed 4 9
Not Completed 7 3
Reason Not Completed
Adverse Event             4             0
Withdrawal by Subject             1             0
Trial stopped by sponsor             1             3
Lack of Efficacy             1             0
Period Title: Period 2
Started 8 9
Completed 7 5
Not Completed 1 4
Reason Not Completed
Adverse Event             0             1
Lack of Efficacy             0             2
Withdrawal by Subject             1             1
Arm/Group Title All Subjects
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
57.2  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
10
  43.5%
Male
13
  56.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants
Netherlands 17
France 6
1.Primary Outcome
Title Leakage
Hide Description The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Time Frame 14+/-3 days per product
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population
Arm/Group Title Coloplast Test Product Standard Care
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 20 19
Overall Number of Units Analyzed
Type of Units Analyzed: Baseplates
145 180
Measure Type: Number
Unit of Measure: percentage of baseplates with no leakage
50 77
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coloplast Test Product Standard Care
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Coloplast Test Product Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Coloplast Test Product Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coloplast Test Product Standard Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/20 (40.00%)      6/20 (30.00%)    
Skin and subcutaneous tissue disorders     
Peristomal skin problem/pain/itching  [1]  8/20 (40.00%)  9 6/20 (30.00%)  6
Indicates events were collected by systematic assessment
[1]
Possibly related to the product
Early termination leading to small number of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director Clinical Affairs
Organization: Coloplast A/S
EMail: dkdac@coloplast.com
Layout table for additonal information
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01994863    
Other Study ID Numbers: CP224
First Submitted: February 26, 2013
First Posted: November 26, 2013
Results First Submitted: February 19, 2015
Results First Posted: March 11, 2015
Last Update Posted: March 11, 2015