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

Phase 2

Terminated

• Conditions: Ileostomy - Stoma
• Interventions: Device: Coloplast Test product; Device: Standard Care

• Registration Number: NCT01994863
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-26
• Results First Submitted: 2015-02-19
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-10
• Last Update Submitted: 2015-03-10
• Results First Posted: 2015-03-11
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Standard Care (see below); Then coloplast test product	Standard Care	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.
First Standard Care (see below); Then coloplast test product	Coloplast Test product	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.
First Coloplast Test product; then Standard Care (see below)	Coloplast Test product	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.
First Coloplast Test product; then Standard Care (see below)	Standard Care	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.

Primary Outcome Measures

Name	Time	Method
Leakage	14+/-3 days per product	The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.

Trial Locations

Locations (1)

QPS Netherland B.V.; 🇳🇱 Groningen, Netherlands