Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy

NCT ID: NCT01957475

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-05-31

Brief Summary

The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances

Conditions

Stoma - Ileostomy

Study Design

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

Study Groups

First Coloplast Test product Z; then Coloplast Test product Y

The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y

Group Type: EXPERIMENTAL

Coloplast Test product Y

Intervention Type: DEVICE

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

Coloplast Test product Z

Intervention Type: DEVICE

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

First Coloplast Test product Y, Then Coloplast Test product Z

The subjects first test test product Y and after cross-over test product Z

Group Type: EXPERIMENTAL

Coloplast Test product Y

Intervention Type: DEVICE

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

Coloplast Test product Z

Intervention Type: DEVICE

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

Interventions

Coloplast Test product Y

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

Intervention Type: DEVICE

Coloplast Test product Z

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

Intervention Type: DEVICE

Other Intervention Names

Coloplast 2-piece Convex appliance Test product Y; Coloplast 2-piece convex appliance test product Z

Eligibility Criteria

Inclusion Criteria

1. Have given written informed consent and signed letter of authority.

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

3. Have had their ileostomy for at least 3 months.

4. Have used a 2-piece convex ostomy product during the last month.

5. Are willing and able to comply with investigation procedures.

6. Have an ileostomy with a diameter of 30 mm or less.

7. Have experienced leakage (seeping) under the baseplate at least 2 times during the last two weeks.

Exclusion Criteria

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).

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

3. Currently receiving or have within the past month received local (peristomal area) or systemic steroid treatment.

4. Are pregnant or breastfeeding.

5. Have a loop ostomy (also called double-barrel or ostomy with two outlets).

6. Known hypersensitivity toward any of the test products.

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

• 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

Coloplast A/S

Humlebæk, , Denmark

Countries

Denmark

Other Identifiers

CP240

Identifier Type: -

Identifier Source: org_study_id