Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

NCT ID: NCT01799239

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-03-31

Brief Summary

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

Conditions

Ileostomy - Stoma

Study Design

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

Study Groups

First Test product; then SenSura

The subject in this arm first test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details.

After cross-over the subject test SenSura which is CE-marked and commerical available.

Group Type: EXPERIMENTAL

Test product

Intervention Type: DEVICE

The test product consists of an adhesive with a new top film

SenSura

Intervention Type: DEVICE

SenSura is the CE-marked and commercially available comparator product

First SenSura, Then Test product

The subject in this arm first test SenSura which is CE-marked and commerical available.

After cross-over the subject test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details.

Group Type: ACTIVE_COMPARATOR

Test product

Intervention Type: DEVICE

The test product consists of an adhesive with a new top film

SenSura

Intervention Type: DEVICE

SenSura is the CE-marked and commercially available comparator product

Interventions

Test product

The test product consists of an adhesive with a new top film

Intervention Type: DEVICE

SenSura

SenSura is the CE-marked and commercially available comparator product

Intervention Type: DEVICE

Eligibility Criteria

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 bags themselves

4. Have an ileostomy with a diameter between 15 and 55 mm

5. Have had their ileostomy for at least 3 months

6. Currently use a 1-piece flat ostomy appliance with open bag

7. Use minimum 1 product every second day, i.e. maximum 2 days wear time

8. Be suitable for participation in the study and for using a standard adhesive, flat base plate

9. Must be able and willing to use custom cut products

10. Accept to test two 1-piece products within the study period

Exclusion Criteria

1. Use irrigation during the study period (flush the intestines with water)

2. Currently receiving or have within the past 2 months received chemotherapy or radiation therapy

3. Currently receiving or have within the past month received systematic 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. Currently using a ostomy belt

7. Currently using extended wear product

8. Have a loop ileostomy

9. Known hypersensitivity towards any of the test products

10. Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study 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

Skövde Hospital

Skövde, , Sweden

Countries

Sweden

Other Identifiers

CP237

Identifier Type: -

Identifier Source: org_study_id