Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy

NCT01957462 | Completed Results

• 1 other identifier: CP239
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.

Conditions

Ileostomy - Stoma; Colostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Degree of Leakage

  The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome). The degree of leakage is measured at each baseplate change

  14 days

Study Arms (2)

FirstColplast Test V, Then Coloplast Test X

EXPERIMENTAL

The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X

Device: Coloplast Test V; Device: Coloplast Test X

First Coloplast Test X, Then Coloplast Test V

EXPERIMENTAL

The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V

Device: Coloplast Test V; Device: Coloplast Test X

Interventions

Coloplast Test V DEVICE

Coloplast Test product V is a newly developed 1-piece ostomy appliance

Also known as: Coloplast 1-piece convex Test product V

First Coloplast Test X, Then Coloplast Test V; FirstColplast Test V, Then Coloplast Test X

Coloplast Test X DEVICE

Coloplast Test X is a newly developed 1-piece ostomy appliance

Also known as: Coloplast 1-piece convex Test product X

First Coloplast Test X, Then Coloplast Test V; FirstColplast Test V, Then Coloplast Test X

Eligibility Criteria

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

You may qualify if:

• Have given written informed consent and signed letter of authority.
• Are at least 18 years of age and have full legal capacity.
• Have had their ostomy (ileo- or colostomy) for at least 3 months.
• Have used a 1-piece convex ostomy product during the last month.
• Are willing and able to comply with investigation procedures.
• Have a ostomy with a diameter of 33 mm or less.

You may not qualify if:

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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Results Point of Contact

• Title: Daniel Carter
• Organization: Coloplast

dkdac@coloplast.com

+45 49222523

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: August 6, 2013
• First Posted: October 8, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 26, 2016
• Results First Posted: August 11, 2014

Record last verified: 2016-08

Locations

DK (1)