Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

NCT01957475 | Completed Results

• 1 other identifier: CP240
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances

Conditions

Stoma - Ileostomy

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 (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was measured at each baseplate change.

  14 days

Study Arms (2)

First Coloplast Test product Z; then Coloplast Test product Y

EXPERIMENTAL

The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y

Device: Coloplast Test product Y; Device: Coloplast Test product Z

First Coloplast Test product Y, Then Coloplast Test product Z

EXPERIMENTAL

The subjects first test test product Y and after cross-over test product Z

Device: Coloplast Test product Y; Device: Coloplast Test product Z

Interventions

Coloplast Test product Y DEVICE

Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance

Also known as: Coloplast 2-piece Convex appliance Test product Y

First Coloplast Test product Y, Then Coloplast Test product Z; First Coloplast Test product Z; then Coloplast Test product Y

Coloplast Test product Z DEVICE

Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance

Also known as: Coloplast 2-piece convex appliance test product Z

First Coloplast Test product Y, Then Coloplast Test product Z; First Coloplast Test product Z; then Coloplast Test product Y

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 ileostomy for at least 3 months.
• Have used a 2-piece convex ostomy product during the last month.
• Are willing and able to comply with investigation procedures.
• Have an ileostomy with a diameter of 30 mm or less.
• Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.

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.
• 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 49112523

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 20, 2016
• Results First Posted: August 11, 2014

Record last verified: 2016-08

Locations

DK (1)