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Investigation of Newly Developed Ostomy Products 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: 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

Tracking Information
First Submitted Date  ICMJE October 18, 2013
First Posted Date  ICMJE November 26, 2013
Results First Submitted Date  ICMJE November 3, 2015
Results First Posted Date  ICMJE January 12, 2016
Last Update Posted Date January 12, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2015)
Degree of Leakage [ Time Frame: 28 +/- 3 days ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
Degree of Leakage [ Time Frame: 28 +/- 3 days ]
The degree of leakage is measured using a 33-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 Ostomy Products in Subjects With Ileostomy
Official Title  ICMJE Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.
Brief Summary The aim of the investigation was to investigate the performance and safety of a new ostomy product.
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 Stoma Ileostomy
Intervention  ICMJE
  • Device: Coloplast test product
    The Coloplast test product is a newly developed ostomy appliance
  • Device: SenSura Convex Light
    The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
    Other Name: SenSura
Study Arms  ICMJE
  • Experimental: First Coloplast test product

    The subjects test:

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

    Interventions:
    • Device: Coloplast test product
    • Device: SenSura Convex Light
  • Experimental: First SenSura Convex Light

    The subjects test:

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

    Interventions:
    • Device: Coloplast test product
    • Device: SenSura Convex Light
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: December 8, 2015)
129
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2013)
223
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Are at least 18 years of age and have full legal capacity.
  2. Has had an ileostomy for at least 3 months.
  3. Has used a convex ostomy product for the last month.
  4. Has given signed informed consent.
  5. Has experienced seeping under the baseplate at least three times during the last two weeks.
  6. Currently using a SenSura Convex product with midi, maxi or magnum bags.
  7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
  8. Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.

Exclusion Criteria:

  1. Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
  2. Are pregnant or breastfeeding.
  3. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
  4. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
  5. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
  6. Are currently participating in another clinical intervention study or have previously participated in this one.
  7. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
  8. Has known hypersensitivity toward the test product.
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 Denmark,   France,   Germany,   Norway,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994902
Other Study ID Numbers  ICMJE CP232
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
Study Director: Daniel Carter Coloplast A/S
PRS Account Coloplast A/S
Verification Date December 2015

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