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Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy

NCT03572673 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-06-28

No results posted yet for this study

Summary

To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.

Conditions

  • Enterostomy

Interventions

DEVICE

Flexima 3S

Flexima 3S (2-piece appliance) with drainable pouch

DEVICE

New 2-piece ostomy appliance

New 2-piece ostomy appliance with drainable pouch

Sponsors & Collaborators

  • BBraun Medical SAS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • Malaysia

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 NCT03572673 on ClinicalTrials.gov