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

Ileostomy - Stoma Clinical Trial

Official title:

An Open-labeled, Randomised, Controlled, Comparative, Cross-over Study Investigating the Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care 1-piece in Subjects With Ileostomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01994863
• Other study ID #: CP224
• Status: Terminated
• Phase: Phase 2
• First received: February 26, 2013
• Last updated: March 10, 2015
• Start date: September 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2015
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Device:
• Coloplast Test product
Coloplast test product is a newly developed 1-piece ostomy appliance
• Standard Care
Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima

Locations

Country	Name	City	State
Netherlands	QPS Netherland B.V.	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No