NCT03325725

Withdrawn

Intra-laryngeal Implant for Treatment of Chronic Aspirations

ProTiP Medical Source

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Other study identifiers

Sponsor study identifier

NB_LD

Study Type

interventional

Actual enrollment (reported)

0

Locations

1 country

Sites

2

Timeline

Study Start

January 9, 2018

Actual (reported)

Primary Completion

January 9, 2018

Actual (reported)

Study Completion

January 9, 2018

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: January 9, 2018
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 17, 2017
Actual (reported)
First Posted
October 30, 2017
Actual (reported)
Study Start
January 9, 2018
Actual (reported)
Primary Completion
January 9, 2018
Actual (reported)
Study Completion
January 9, 2018
Actual (reported)

Last Updated: January 12, 2018
Status Verified: January 2018
Last Update Submitted: January 9, 2018

Conditions

Aspiration Pneumonia Tracheostomy Complication

Keywords

severe aspiration

Outcome Measures

Primary Outcomes (1)

Sealing of the NewBreez LD: Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)
Protection of the lower airways will be assessed using the gold standard exam, videofluoroscopy (VFS)
7 days

Other Outcomes (2)

Stability of the NewBreez LD: Number of patients who kept the implant until the end of the study period.
30 days
Safety of the NewBreez LD: Number of patient with adverse events will be assessed at each follow-up during the study period
2, 7, 30 days

Study Arms (1)

NewBreez LD Intra-laryngeal implant

EXPERIMENTAL

Device: NewBreez LD intra-laryngeal implant

Interventions

NewBreez LD intra-laryngeal implantDevice

NewBreez LD intra-laryngeal implantation

NewBreez LD Intra-laryngeal implant

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Swallowing disorders characterized by chronic aspirations;
Tracheotomy performed, inter alia, in the management of swallowing disorders;

Sponsors & Collaborators

ProTiP Medical
Industrylead

Study Sites (2)

CHU Strasbourg

Strasbourg, 67000, France

CHU Toulouse

Toulouse, 31000, France

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

Christian Debry, Pr.
CHU Strasbourg
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DEVICE FEASIBILITY
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 30, 2017

Study Start

January 9, 2018

Actual (reported)

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Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask

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Not ApplicableCompleted

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Not ApplicableUnknown

Aged over 18;

Willing and able to comply with the requirements of the study;

Informed consent signed;

Affiliated patient or beneficiary of the social security system.

You may not qualify if:

Do not implant in patients with incomplete cricoid cartilage (surgery or other);
Do not implant in patients with tracheotomy performed by cricothyroidectomy or between cricoid cartilage and the 1st tracheal ring;
Do not implant in patients with tracheal lumen in the 1st tracheal ring, the lateral and anteroposterior diameters of which are less than 11 mm;
Do not implant in patients with tight trismus;
Do not implant in subjects less than 18 years of age;
Do not implant in patients with bleeding disorders;
Do not implant in patients contraindicated to general anesthesia.

Contact the study team to confirm eligibility.

Primary Completion

January 9, 2018

Actual (reported)

Study Completion

January 9, 2018

Actual (reported)

Last Updated

January 12, 2018

Record last verified: 2018-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03325725
Data provider: ClinicalTrials.gov
Source updated: 2018-01-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:45 UTC

Locations

FR(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Other Outcomes (2)

Study Arms (1)

NewBreez LD Intra-laryngeal implant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations