Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

NCT01994863 | Terminated Phase 2 Results

• 1 other identifier: CP224
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Leakage

  The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.

  14+/-3 days per product

Study Arms (2)

First Coloplast Test product; then Standard Care (see below)

EXPERIMENTAL

The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation.

Device: Coloplast Test product; Device: Standard Care

First Standard Care (see below); Then coloplast test product

EXPERIMENTAL

The subjects are randomised to test Standard care first and thereafter test Coloplast test product. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation.

Device: Coloplast Test product; Device: Standard Care

Interventions

Coloplast Test product DEVICE

Coloplast test product is a newly developed 1-piece ostomy appliance

Also known as: Coloplast 1-piece test product

First Coloplast Test product; then Standard Care (see below); First Standard Care (see below); Then coloplast test product

Standard Care DEVICE

Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima

Also known as: Coloplast SenSura, Hollister Moderma/Moderma Flex, B.Braun Flexima/Softima

First Coloplast Test product; then Standard Care (see below); First Standard Care (see below); Then coloplast test product

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
• Be at least 18 years of age and have full legal capacity
• Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)
• Have an ileostomy with a diameter between 15 and 45 mm
• Have had their ostomy for at least three months
• Currently use a 1-piece flat product with open bag
• Use minimum 1 product every second day.
• Be suitable for participation in the investigation and for using a standard adhesive, flat base plate
• Must use custom cut product
• Accept to test two 1-piece products within the study

You may not qualify if:

• Use irrigation during the study (flush the stoma with water)
• Currently receiving or have within the past 2 months received radio- and/or chemotherapy
• Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
• Are pregnant or breastfeeding
• Participating in other interventional clinical investigations or have previously participated in this investigation
• Has more than three days wear time

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

QPS Netherland B.V.

Groningen, 9713 GZ, Netherlands

Location

Limitations and Caveats

Early termination leading to small number of subjects analyzed

Results Point of Contact

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

dkdac@coloplast.com

Study Officials

• Daniel Carter, MSc

  Coloplast A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: November 26, 2013
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 11, 2015
• Results First Posted: March 11, 2015

Record last verified: 2015-03

Locations

NL (1)