Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy

The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.

Study Overview

• Status: Completed
• Conditions: Subjects With an Ileostomy
• Intervention / Treatment: Device: Coloplast A; Device: Coloplast B; Device: SenSura Click; Device: Coloplast C

Detailed Description

The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Have given written informed consent and signed letter of authority form.
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the appliances themselves
4. Have an ileostomy with a diameter between 15 and 40 mm.
5. Have had their ostomy for at least three months.
6. Use minimum 1 baseplate every third day.
7. Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
8. Must be able to use custom cut product
9. Accept to test three 2-piece products within the study.
10. Negative result of a pregnancy test for women of childbearing age.

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 local or systemic steroid 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. More than three days wear time as usual change pattern.
7. Currently using ostomy belt
8. Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
9. Have a loop ileostomy
10. Known hypersensitivity towards any of the test products
11. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment sequence 1; Subjects randomised to Treatment sequence 1 will test three different products: Coloplast A; Coloplast B; SenSura Click The subjects test the three test products in a randomized order: ABS; BSA, SAB	Device: Coloplast A; Coloplast A is a newly developed 2-piece ostomy appliance; Device: Coloplast B; Coloplast B is a newly developed 2-piece ostomy appliance; Device: SenSura Click; The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.
Experimental: Treatment sequence 2; Subjects randomised to Treatment sequence 2 will test three different products: Coloplast C (C); Coloplast B (B); SenSura Click (S) The subjects test the three test products in a randomized order: CBS; BSC, SCB	Device: Coloplast B; Coloplast B is a newly developed 2-piece ostomy appliance; Device: SenSura Click; The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.; Device: Coloplast C; Coloplast C is a newly developed 2-piece ostomy appliance
Experimental: Treatment sequence 3; Subjects randomised to Treatment sequence 3 will test three different products: Coloplast A (A); Coloplast C (C); SenSura Click (S) The subjects test the three test products in a randomized order: ACS; CSA, SAC	Device: Coloplast A; Coloplast A is a newly developed 2-piece ostomy appliance; Device: SenSura Click; The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.; Device: Coloplast C; Coloplast C is a newly developed 2-piece ostomy appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Leakage	The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices; No leakage; Starting to leakage; Leakage; Sudden leakage Leakage was assessed at every baseplate change	10 days

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: stoma ileostomy
• Other Study ID Numbers: CP234