Clinical Trials Directory

Trials / Completed

CompletedNCT02887144

Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
Coloplast A/S · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.

Detailed description

Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.

Conditions

Interventions

TypeNameDescription
DEVICESenSuraSenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S
DEVICESenSura test productSenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S

Timeline

Start date
2016-01-01
Primary completion
2016-08-01
Completion
2016-08-01
First posted
2016-09-02
Last updated
2016-09-02

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT02887144. Inclusion in this directory is not an endorsement.