Investigation of a New 1-piece Convex Ostomy Product

NCT02043782 | Completed Results

• 1 other identifier: CP241
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the investigation was to investigate the performance and safety of a new ostomy product

Conditions

Stoma Ileostomy; Stoma Colostomy

Outcome Measures

Primary Outcomes (1)

• Degree of Leakage

  The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.

  14 +/- 3 days

Study Arms (3)

First Coloplast Test

EXPERIMENTAL

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Coloplast Test; Secondly to either 1. Own product (baseline) 2. Competitor soft convex

Device: Coloplast Test; Device: Own product; Device: Competitor soft convex

First Competitor soft convex

EXPERIMENTAL

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Competitor soft convex; Secondly to either 1. Own product (baseline) 2. Coloplast Test

Device: Coloplast Test; Device: Own product; Device: Competitor soft convex

First Own product

EXPERIMENTAL

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Own product; Secondly to either 1. Coloplast Test 2. Competitor soft convex

Device: Coloplast Test; Device: Own product; Device: Competitor soft convex

Interventions

Coloplast Test DEVICE

Newly developed 1-piece convex ostomy product

First Coloplast Test; First Competitor soft convex; First Own product

Own product DEVICE

The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.

First Coloplast Test; First Competitor soft convex; First Own product

Competitor soft convex DEVICE

A commercially available soft convex product

First Coloplast Test; First Competitor soft convex; First Own product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 18 years of age and have full legal capacity.
• Have had an ileostomy/colostomy for more than 3 months
• Have used a 1-piece flat ostomy product for the last 1 month
• Has given written Informed Consent and signed the letter of authority
• Have an ileostomy or colostomy with a diameter of 33 mm or less
• Has experienced leakage (seeping) under the baseplate at least three times during the last two weeks
• Are evaluated to be suitable for a soft convex product
• If having a colostomy: changes their product on average 2 times pr. 24h or more
• Currently uses a bag of size medi/midi or maxi

You may not qualify if:

• Have a loop ostomy (also called double-barrel or ostomy with two outlets).
• Are pregnant or breastfeeding
• Currently receiving or have within the past 2 month received radio- and/or chemotherapy
• Currently receiving or have within the past month received systemic or local steroid treatment in the peristomal area
• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
• Known hypersensitivity toward any of the test products
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Use irrigation during the investigation (flush the intestine with water)
• Have a fistula in the peristomal area or less than 2 cm from the edge of the baseplate
• If subject has a colostomy: empties the bag

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

TFS

Søborg, Denmark

Location

Results Point of Contact

• Title: Medical Director
• Organization: Coloplast A/S

dkbir@coloplast.com

+45 4911 1395

Study Officials

• Birte P Jakobsen, MD

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 23, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 4, 2016
• Results First Posted: December 8, 2015

Record last verified: 2016-03

Locations

DK (1)