Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece 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: 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

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.

Condition or disease Intervention/treatment Phase
Ileostomy - Stoma Device: Coloplast Test product Device: Standard Care Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arm Intervention/treatment
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.

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

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.

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01994863


Locations
Layout table for location information
Netherlands
QPS Netherland B.V.
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Coloplast A/S
Investigators
Layout table for investigator information
Study Director: Daniel Carter, MSc Coloplast A/S
Layout table for additonal information
Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01994863    
Other Study ID Numbers: CP224
First Posted: November 26, 2013    Key Record Dates
Results First Posted: March 11, 2015
Last Update Posted: March 11, 2015
Last Verified: March 2015