Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

• 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: Coloplast A/S
• Information provided by (Responsible Party): Coloplast A/S

Tracking Information

• First Submitted Date: October 18, 2013
• First Posted Date: November 26, 2013
• Results First Submitted Date: November 3, 2015
• Results First Posted Date: January 12, 2016
• Last Update Posted Date: January 12, 2016
• Study Start Date: November 2013
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Stoma Ileostomy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 8, 2015): 129
• Original Estimated Enrollment (submitted: November 21, 2013): 223
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, France, Germany, Norway, United Kingdom

Administrative Information

• NCT Number: NCT01994902
• Other Study ID Numbers: CP232
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Coloplast A/S
• Study Sponsor: Coloplast A/S
• Collaborators: Not Provided

Investigators

• Study Director: Daniel Carter; Coloplast A/S

• PRS Account: Coloplast A/S
• Verification Date: December 2015