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

NCT01994876 | Completed Results

• 1 other identifier: CP229
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Degree of Leakage

  The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)

  14 days

Study Arms (2)

First Coloplast Test 1

EXPERIMENTAL

The subjects first test their own product to collect a baseline measurement The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2

Device: Coloplast Test 1; Device: Coloplast Test 2

First Coloplast Test 2

EXPERIMENTAL

The subjects first test their own product to collect baseline measurements The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1

Device: Coloplast Test 1; Device: Coloplast Test 2

Interventions

Coloplast Test 1 DEVICE

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

First Coloplast Test 1; First Coloplast Test 2

Coloplast Test 2 DEVICE

Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance

First Coloplast Test 1; First Coloplast Test 2

Eligibility Criteria

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

You may qualify if:

• Subjects must comply with the following criteria in order to participate in the investigation:
• Are at least 18 years of age and have full legal capacity
• Have had an ileostomy for at least 3 months
• Have used a convex ostomy appliance for the last month
• Have given written informed consent
• Have an ileostomy with a diameter of 33 mm or less
• Have experience leakage (seeping) under the baseplate at least two times over the last two weeks

You may not qualify if:

• Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
• Have a loop ostomy (also called double-barrel or ostomy with two outlets)
• Are pregnant or breastfeeding
• Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
• Currently receiving or have received, within the last month, systemic or local steroid treatment (adreno-cortical hormone) in the peristomal area
• Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
• Are currently participating in another clinical investigation or has previously participated in this investigation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

QPS

Groningen, 9713, Netherlands

Location

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Coloplast A/S

dkdac@coloplast.com

+45 4911 25 23

Study Officials

• Kalid S Abd-Elaziz, MD

  QPS Holdings LLC

  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: October 1, 2013
• First Posted: November 26, 2013
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-02

Locations

NL (1)