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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

Tracking Information
First Submitted Date  ICMJE October 1, 2013
First Posted Date  ICMJE November 26, 2013
Results First Submitted Date  ICMJE February 26, 2014
Results First Posted Date  ICMJE April 7, 2014
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2014)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
Degree of Leakage [ Time Frame: 14 days ]
The degree of leakage was measured with a 32-point scale developed by Coloplast A/S
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
Official Title  ICMJE Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
Brief Summary To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Ileostomy - Stoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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

    Interventions:
    • Device: Coloplast Test 1
    • Device: Coloplast Test 2
  • 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

    Interventions:
    • Device: Coloplast Test 1
    • Device: Coloplast Test 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2013)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994876
Other Study ID Numbers  ICMJE CP229
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Coloplast A/S
Study Sponsor  ICMJE Coloplast A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kalid S Abd-Elaziz, MD QPS
PRS Account Coloplast A/S
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP