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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

Study Description
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Brief Summary:
The aim of the investigation was to investigate the performance and safety of a new ostomy product.

Condition or disease Intervention/treatment Phase
Stoma Ileostomy Device: Coloplast test product Device: SenSura Convex Light Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.
Study Start Date : November 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arms and Interventions
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Arm Intervention/treatment
Experimental: First Coloplast test product

The subjects test:

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

 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
Experimental: First SenSura Convex Light

The subjects test:

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

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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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:

  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.
Contacts and Locations
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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): NCT01994902


Locations
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Sponsors and Collaborators
Coloplast A/S
Investigators
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Study Director: Daniel Carter Coloplast A/S
More Information
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01994902    
Other Study ID Numbers: CP232
First Posted: November 26, 2013    Key Record Dates
Results First Posted: January 12, 2016
Last Update Posted: January 12, 2016
Last Verified: December 2015