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Intra-laryngeal Implant for Treatment of Chronic Aspirations

NCT03325725 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-01-12

No results posted yet for this study

Summary

This study evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and may lead to complications, including inhalation pneumonia.

Conditions

  • Aspiration Pneumonia
  • Tracheostomy Complication

Interventions

DEVICE

NewBreez LD intra-laryngeal implant

NewBreez LD intra-laryngeal implantation

Sponsors & Collaborators

  • ProTiP Medical

    lead INDUSTRY

Principal Investigators

  • Christian Debry, Pr. · CHU Strasbourg

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2018-01-09
Completion
2018-01-09

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 NCT03325725 on ClinicalTrials.gov