Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy

NCT02223104 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-07-31

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.

Conditions

  • Colostomy

Interventions

DEVICE

Flexima Active

DEVICE

Sensura

Sponsors & Collaborators

  • BBraun Medical SAS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02223104 on ClinicalTrials.gov