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Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

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ClinicalTrials.gov Identifier: NCT01994902
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : January 12, 2016
Last Update Posted : January 12, 2016
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 Stoma Ileostomy
Interventions Device: Coloplast test product
Device: SenSura Convex Light
Enrollment 129
Recruitment Details  
Pre-assignment Details 129 subjects were randomized, but two of these subjects were not exposed to a product: one subject had a stoma diameter of 42 mm (violation to inclusion criteria no.8) and one subject had chemotherapy planned (exclusion criteria no.3). 127 subjects were therefore included in the ITT population.
Arm/Group Title First Coloplast Test Product; Then SenSura Convex Light First SenSura Convex Light; Then Coloplast Test Product
Hide Arm/Group Description

The subjects test:

test period 1: Coloplast test product test period 2: SenSura Convex Light

.

The subjects test:

test period 1: SenSura Convex Light test period 2: Coloplast test product

Period Title: Test Period 1
Started 63 64 [1]
Completed 57 61 [2]
Not Completed 6 3
Reason Not Completed
Withdrawal by Subject             3             0
device deficiency with adverse event             0             1
Adverse Event             2             1
Lack of Efficacy             0             1
bag too small             1             0
[1]
Randomisation mistake:a subject randomised to SenSura Convex Light but tested Coloplast test product
[2]
The subject testing Coloplast test product discontinued due to device deficiency with adverse event
Period Title: Test Period 2
Started 57 61
Completed 57 55
Not Completed 0 6
Reason Not Completed
Withdrawal by Subject             0             2
Lack of Efficacy             0             1
Other             0             3
Arm/Group Title Overall Study
Hide Arm/Group Description The investigation is a cross-over investigation therefore the baseline data is given for the overall study population
Overall Number of Baseline Participants 127
Hide Baseline Analysis Population Description
Only subjects in the intention to treat population are included in the baseline population. These were the only subjects who tested the products.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants
58.8  (14.1)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants
Female 77
Male 49
[1]
Measure Description: one gender registration was missing
1.Primary Outcome
Title Degree of Leakage
Hide Description The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).
Time Frame 28 +/- 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
The results presented above are the intention-to-treat results that were analysed as randomised. However, the adverse events are reported as treated and as 4 subjects did not follow the randomisation order there is a slight discrepancy between the participants number in the outcome and adverse events section.
Arm/Group Title Coloplast Test Product SenSura Convex Light
Hide Arm/Group Description:
Leakage results obtained while subjects tested the Coloplast test product
The leakage results obtained while subjects were testing SenSura Convex Light
Overall Number of Participants Analyzed 124 121
Overall Number of Units Analyzed
Type of Units Analyzed: Baseplates
1967 1988
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.1  (5.8) 5.8  (5.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coloplast Test Product SenSura Convex Light
Hide Arm/Group Description Adverse events reported by subjects testing Coloplast test product Adverse events reported by subjects testing SenSura Convex Light
All-Cause Mortality
Coloplast Test Product SenSura Convex Light
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Coloplast Test Product SenSura Convex Light
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/125 (4.80%)      3/120 (2.50%)    
Gastrointestinal disorders     
acute abdominal pain  [1]  0/125 (0.00%)  0 1/120 (0.83%)  1
stoma operation (revision of stome)  [2]  1/125 (0.80%)  1 0/120 (0.00%)  0
obstruction of stoma  [2]  1/125 (0.80%)  1 0/120 (0.00%)  0
Blocked stoma  [2]  0/125 (0.00%)  0 1/120 (0.83%)  1
Infections and infestations     
gastrientitis  [2]  1/125 (0.80%)  1 0/120 (0.00%)  0
Severe sepsis in contex of intra abdominal infection  [2]  0/125 (0.00%)  0 1/120 (0.83%)  1
Metabolism and nutrition disorders     
dehydration  [2]  1/125 (0.80%)  1 0/120 (0.00%)  0
Renal and urinary disorders     
urinary tract infection  [1]  1/125 (0.80%)  1 0/120 (0.00%)  0
renal failure  [2]  1/125 (0.80%)  1 0/120 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
unlikely related to the device
[2]
not related to product
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Coloplast Test Product SenSura Convex Light
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/125 (22.40%)      14/120 (11.67%)    
Skin and subcutaneous tissue disorders     
Skin irritations   28/125 (22.40%)  51 14/120 (11.67%)  26
Indicates events were collected by systematic assessment
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: Medical Director
Organization: Coloplast A/S
Phone: +45 49111395
EMail: dkbir@coloplast.com
Layout table for additonal information
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01994902    
Other Study ID Numbers: CP232
First Submitted: October 18, 2013
First Posted: November 26, 2013
Results First Submitted: November 3, 2015
Results First Posted: January 12, 2016
Last Update Posted: January 12, 2016