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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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

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




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994876


Locations
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Netherlands
QPS
Groningen, Netherlands, 9713
Sponsors and Collaborators
Coloplast A/S
Investigators
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Principal Investigator: Kalid S Abd-Elaziz, MD QPS
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01994876    
Other Study ID Numbers: CP229
First Posted: November 26, 2013    Key Record Dates
Results First Posted: April 7, 2014
Last Update Posted: April 7, 2014
Last Verified: February 2014