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

NCT ID: NCT01800890

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-04-30

Brief Summary

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

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.

Conditions

Subjects With an Ileostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treatment sequence 1

Subjects randomised to Treatment sequence 1 will test three different products:

1. Coloplast A

2. Coloplast B

3. SenSura Click

The subjects test the three test products in a randomized order: ABS; BSA, SAB

Group Type: OTHER

Coloplast A

Intervention Type: DEVICE

Coloplast A is a newly developed 2-piece ostomy appliance

Coloplast B

Intervention Type: DEVICE

Coloplast B is a newly developed 2-piece ostomy appliance

SenSura Click

Intervention Type: DEVICE

The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.

Treatment sequence 2

Subjects randomised to Treatment sequence 2 will test three different products:

1. Coloplast C (C)

2. Coloplast B (B)

3. SenSura Click (S)

The subjects test the three test products in a randomized order: CBS; BSC, SCB

Group Type: EXPERIMENTAL

Coloplast B

Intervention Type: DEVICE

Coloplast B is a newly developed 2-piece ostomy appliance

Coloplast C

Intervention Type: DEVICE

Coloplast C is a newly developed 2-piece ostomy appliance

SenSura Click

Intervention Type: DEVICE

The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.

Treatment sequence 3

Subjects randomised to Treatment sequence 3 will test three different products:

1. Coloplast A (A)

2. Coloplast C (C)

3. SenSura Click (S)

The subjects test the three test products in a randomized order: ACS; CSA, SAC

Group Type: EXPERIMENTAL

Coloplast A

Intervention Type: DEVICE

Coloplast A is a newly developed 2-piece ostomy appliance

Coloplast C

Intervention Type: DEVICE

Coloplast C is a newly developed 2-piece ostomy appliance

SenSura Click

Intervention Type: DEVICE

The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.

Interventions

Coloplast A

Coloplast A is a newly developed 2-piece ostomy appliance

Intervention Type: DEVICE

Coloplast B

Coloplast B is a newly developed 2-piece ostomy appliance

Intervention Type: DEVICE

Coloplast C

Coloplast C is a newly developed 2-piece ostomy appliance

Intervention Type: DEVICE

SenSura Click

The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Carter, MSc

Role: STUDY_CHAIR

Coloplast A/S

Locations

Coloplast A/S

Humlebæk, , Denmark

Countries

Denmark

Other Identifiers

CP234

Identifier Type: -

Identifier Source: org_study_id