A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.

NCT02064231 | Completed Results

• 1 other identifier: CP222
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Degree of Leakage

  Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).

  14 days

Study Arms (2)

Coloplast Test A, Coloplast Test B, Own product

EXPERIMENTAL

The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days

Device: Coloplast Test A; Device: Coloplast Test B; Device: Own product

Coloplast Test C , Coloplast Test D, Own product

EXPERIMENTAL

The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days

Device: Own product; Device: Coloplast Test C; Device: Coloplast Test D

Interventions

Coloplast Test A DEVICE

Coloplast Test A is a new ostomy appliance developed by Coloplast A/S

Coloplast Test A, Coloplast Test B, Own product

Coloplast Test B DEVICE

Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S

Coloplast Test A, Coloplast Test B, Own product

Own product DEVICE

Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.

Coloplast Test A, Coloplast Test B, Own product; Coloplast Test C , Coloplast Test D, Own product

Coloplast Test C DEVICE

Coloplast Test C is a new ostomy appliance developed by Coloplast A/S

Coloplast Test C , Coloplast Test D, Own product

Coloplast Test D DEVICE

Coloplast Test D is a new ostomy appliance developed by Coloplast A/S

Coloplast Test C , Coloplast Test D, Own product

Eligibility Criteria

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

You may qualify if:

• Had given written informed consent
• Was at least 18 years of age
• Was able to handle the appliances themselves or with help from a caregiver (e.g. spouse)
• Had an ileostomy with a diameter between 15-45 mm
• Have had an ileostomy for at least 3 months
• Currently used a 2-piece flat appliance

You may not qualify if:

• Used irrigation during the investigation (flush stoma with water)
• Currently received or had within the past 2 months received radio- and/or chemotherapy.
• Currently received or had within the past month received local or systemic steroid treatment in the peristomal area.
• Was pregnant or breast feeding
• Participated in other interventional studies that could interfere with this one or had previously participated in this investigation.
• Had a baseplate wear time of more than three days
• Suffered from peristomal skin problems that precluded participation in the investigation (assessed by the investigation nurse)

Sponsors & Collaborators

• Coloplast A/S: lead

Results Point of Contact

• Title: Birte Petersen Jakobsen, MD
• Organization: Coloplast A/S

dkbir@coloplast.com

+45 4911 1395

Study Officials

• Birte p Jakobsen, MD

  Medical director

  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: February 13, 2014
• First Posted: February 17, 2014
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 10, 2020
• Results First Posted: April 4, 2014

Record last verified: 2020-08