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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01799239
Other study ID # CP237
Secondary ID
Status Completed
Phase N/A
First received February 22, 2013
Last updated October 7, 2013
Start date February 2013
Est. completion date March 2013

Study information

Verified date October 2013
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Test product
The test product consists of an adhesive with a new top film
SenSura
SenSura is the CE-marked and commercially available comparator product

Locations

Country Name City State
Sweden Skövde Hospital Skövde

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Leakage (Percentage of All Baseplates With Leakage) leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.
The subjects tick of one of the four possible answers:
No leakage
Starting to leak
Leakage
Sudden leakage
After each baseplate change over a period, of 7 days No
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