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Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

NCT02507726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-09-23

No results posted yet for this study

Summary

This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.

Conditions

  • Enterostomy

Interventions

DEVICE

Flexima Active soft convexe

The Investigational Device will be used during 14 +- 3 days.

Sponsors & Collaborators

  • BBraun Medical SAS

    lead INDUSTRY

Principal Investigators

  • Patrick RAT, MD · University Hospital of Dijon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-09-30
Completion
2016-09-30

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 NCT02507726 on ClinicalTrials.gov