Investigation of a New 1-piece Convex Ostomy Product

NCT ID: NCT02043782

Last Updated: 2016-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-04-30

Brief Summary

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

Conditions

Stoma Ileostomy; Stoma Colostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

First Coloplast Test

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

Group Type: EXPERIMENTAL

Coloplast Test

Intervention Type: DEVICE

Newly developed 1-piece convex ostomy product

Own product

Intervention Type: 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.

Competitor soft convex

Intervention Type: DEVICE

A commercially available soft convex product

First Competitor soft convex

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

Group Type: EXPERIMENTAL

Coloplast Test

Intervention Type: DEVICE

Newly developed 1-piece convex ostomy product

Own product

Intervention Type: 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.

Competitor soft convex

Intervention Type: DEVICE

A commercially available soft convex product

First Own product

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

Group Type: EXPERIMENTAL

Coloplast Test

Intervention Type: DEVICE

Newly developed 1-piece convex ostomy product

Own product

Intervention Type: 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.

Competitor soft convex

Intervention Type: DEVICE

A commercially available soft convex product

Interventions

Coloplast Test

Newly developed 1-piece convex ostomy product

Intervention Type: DEVICE

Own product

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.

Intervention Type: DEVICE

Competitor soft convex

A commercially available soft convex product

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birte P Jakobsen, MD

Role: PRINCIPAL_INVESTIGATOR

Coloplast A/S

Locations

TFS

Søborg, , Denmark

Countries

Denmark

Other Identifiers

CP241

Identifier Type: -

Identifier Source: org_study_id