NCT01587664

Brief Summary

The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

April 26, 2012

Last Update Submit

April 7, 2017

Conditions

Swallowing Disorders

Keywords

Swallowing disordersAspiration

Outcome Measures

Primary Outcomes (1)

  • Aspiration score at 1 month

    Within-subject relative change-from-baseline at 1 month in aspiration score based on radiographic swallowing study

    1 month

Study Arms (1)

NewBreez ILP

EXPERIMENTAL

Implantation of a NewBreez ILP

Device: NewBreez ILP

Interventions

NewBreez ILPDEVICE

NewBreez ILP implantation

NewBreez ILP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old
  • Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations
  • Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit
  • Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: scanner, radiographic swallowing study, nasopharyngoscopy , NewBreez ILP implant as well as quality-of-life evaluation
  • Must be able to understand and be willing to provide written informed consent

You may not qualify if:

  • Any condition that precludes the insertion of the NewBreez ILP or ancillary implantation device
  • Major swallowing disorder
  • Existing coagulation disorder
  • Previous esophageal stenting
  • Life-expectancy \< 12 months
  • Be pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential)Point of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Mont-Godinne

Yvoir, 5530, Belgium

Location

Hopital Avicenne

Bobigny, 93000, France

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Marc Remacle, Prof.

    UCL Mont-Godinne (Belgium)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 26, 2012

First Posted

April 30, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)FR(1)