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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

Tracking Information
First Submitted Date  ICMJE February 26, 2013
First Posted Date  ICMJE November 26, 2013
Results First Submitted Date  ICMJE February 19, 2015
Results First Posted Date  ICMJE March 11, 2015
Last Update Posted Date March 11, 2015
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: March 10, 2015)
Leakage [ Time Frame: 14+/-3 days per product ]
The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
Leakage under the adhesive and leakage outside the adhesive soiling the clothes in one assessment with 4 pre-defined figures following the CRF standard tool. [ Time Frame: 4 weeks ]
Excretion of faeces (output) which seeps between the skin and the adhesive side of the base plate (the side which is in contact with the skin). To identify the leakage under the base plate the following must be fulfilled: The output appears on the base plate minimum 5 mm from the hole in the base plate. The adhesive side of the base plate is discolored.
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 Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy
Official Title  ICMJE An Open-labeled, Randomised, Controlled, Comparative, Cross-over Study Investigating the Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care 1-piece in Subjects With Ileostomy
Brief Summary The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Ileostomy - Stoma
Intervention  ICMJE
  • Device: Coloplast Test product
    Coloplast test product is a newly developed 1-piece ostomy appliance
    Other Name: Coloplast 1-piece test product
  • Device: Standard Care

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

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

    Other Names:
    • Coloplast SenSura
    • Hollister Moderma/Moderma Flex
    • B.Braun Flexima/Softima
Study Arms  ICMJE
  • Experimental: First Coloplast Test product; then Standard Care (see below)

    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.

    Interventions:
    • Device: Coloplast Test product
    • Device: Standard Care
  • Experimental: First Standard Care (see below); Then coloplast test product

    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.

    Interventions:
    • Device: Coloplast Test product
    • Device: Standard Care
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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 10, 2015)
23
Original Actual Enrollment  ICMJE
 (submitted: November 21, 2013)
25
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:

  1. Have given written informed consent
  2. Be at least 18 years of age and have full legal capacity
  3. Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)
  4. Have an ileostomy with a diameter between 15 and 45 mm
  5. Have had their ostomy for at least three months
  6. Currently use a 1-piece flat product with open bag
  7. Use minimum 1 product every second day.
  8. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate
  9. Must use custom cut product
  10. Accept to test two 1-piece products within the study

Exclusion Criteria:

  1. Use irrigation during the study (flush the stoma with water)
  2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  3. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
  4. Are pregnant or breastfeeding
  5. Participating in other interventional clinical investigations or have previously participated in this investigation
  6. Has more than three days wear time
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 NCT01994863
Other Study ID Numbers  ICMJE CP224
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, MSc Coloplast A/S
PRS Account Coloplast A/S
Verification Date March 2015

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