Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece

NCT ID: NCT01957488

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-09-30

Brief Summary

The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products

Detailed Description

The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products

Conditions

Ileostomy - Stoma

Study Design

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

Study Groups

Treatment sequence 1; First Coloplast Test product 1

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.

Subjects are first allocated to test Coloplast Test product 1 and secondly test either:

1. Coloplast Test product 1 and thereafter Coloplast SenSura

2. Coloplast Sensura and thereafter Coloplast Test product 2

Group Type: EXPERIMENTAL

Coloplast Test Product 1

Intervention Type: DEVICE

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

Coloplast Test Product 2

Intervention Type: DEVICE

Coloplast Test product 2 is a newly developed 1-piece ostomy appliance

Coloplast SenSura

Intervention Type: DEVICE

SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.

Treatment seqence 2; First Coloplast Test product 2.

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.

Subjects are first allocated to test Coloplast Test product 2 and secondly test either:

1. Coloplast Test product 1 and thereafter Coloplast SenSura

2. Coloplast Sensura and thereafter Coloplast Test product 1

Group Type: EXPERIMENTAL

Coloplast Test Product 1

Intervention Type: DEVICE

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

Coloplast Test Product 2

Intervention Type: DEVICE

Coloplast Test product 2 is a newly developed 1-piece ostomy appliance

Coloplast SenSura

Intervention Type: DEVICE

SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.

Treatment sequence 3, First Coloplast SenSura

The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.

Subjects are first allocated to test Coloplast SenSura and secondly test either:

1. Coloplast Test product 2 and thereafter Coloplast Test product 1

2. Coloplast Test product 1 and thereafter Coloplast Test product 2

Group Type: EXPERIMENTAL

Coloplast Test Product 1

Intervention Type: DEVICE

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

Coloplast Test Product 2

Intervention Type: DEVICE

Coloplast Test product 2 is a newly developed 1-piece ostomy appliance

Coloplast SenSura

Intervention Type: DEVICE

SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.

Interventions

Coloplast Test Product 1

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

Intervention Type: DEVICE

Coloplast Test Product 2

Coloplast Test product 2 is a newly developed 1-piece ostomy appliance

Intervention Type: DEVICE

Coloplast SenSura

SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.

Intervention Type: DEVICE

Other Intervention Names

SenSura 1-piece

Eligibility Criteria

Inclusion Criteria

1. Have given written informed consent and signed letter of authority (mandatory in DK)

2. Be at least 18 years of age and have full legal capacity.

3. Be able to handle the products themselves

4. Have an ileostomy with a diameter between 10 and 40 mm.

5. Have had their ostomy for at least three months.

6. Have within the last month used a 1-piece flat product with open bag

7. Currently using midi or maxi bags

8. Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time.

9. Be suitable for participation in the investigation

10. Must be able to use custom cut product

11. Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.

2. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area

3. Are pregnant or breastfeeding

4. Participating in other interventional clinical investigations or have previously participated in this investigation

5. Has participated in the previous explorative Coloplast studies CP236 and CP237

6. Are currently or during the study using ostomy belt

7. Has a stoma below skin surface

8. Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin)

9. Has known hypersensitivity towards any of the test products

• 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

Birte P Jakobsen, MD

Role: PRINCIPAL_INVESTIGATOR

Coloplast A/S

Locations

Holtedam 3

Humlebæk, , Denmark

QPS Nederlands

Groningen, , Netherlands

Sykepleierklinikken

Larvik, , Norway

Synexus Limited

Chorley, Lancashire, United Kingdom

Countries

Denmark; Netherlands; Norway; United Kingdom

Other Identifiers

CP242

Identifier Type: -

Identifier Source: org_study_id