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NCT01957488 Clinical Trial

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

Ileostomy - Stoma Clinical Trial

Official title:
Investigating the Safety and Performance of Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01957488
Other study ID # CP242
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date September 2013

Study information
Verified date August 2020
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 183
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Coloplast Test Product 1
Coloplast Test product 1 is a newly developed 1-piece ostomy appliance
• Coloplast Test Product 2
Coloplast Test product 2 is a newly developed 1-piece ostomy appliance
• Coloplast SenSura
SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.

Locations
Country Name City State
Denmark Holtedam 3 Humlebæk
Netherlands QPS Nederlands Groningen
Norway Sykepleierklinikken Larvik
United Kingdom Synexus Limited Chorley Lancashire

Sponsors (1)
Lead Sponsor Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  Netherlands,  Norway,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Leakage The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change. 14 +- 1 days
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