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NewBreez Safety and Efficacy Evaluation

Primary Purpose

Swallowing Disorders

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NewBreez ILP
Sponsored by
ProTiP Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Swallowing Disorders focused on measuring Swallowing disorders, Aspiration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > 18 years old
  2. Congenital or acquired, central or peripheral, neurological or neuromuscular disorder associated with laryngeal dysfunction with aspirations
  3. Has a tracheotomy or tracheostomy and is indicated for use of a hood weaning kit
  4. 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
  5. Must be able to understand and be willing to provide written informed consent

Exclusion Criteria:

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

Sites / Locations

  • CHU Mont-Godinne
  • Hopital Avicenne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NewBreez ILP

Arm Description

Implantation of a NewBreez ILP

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 26, 2012
Last Updated
April 7, 2017
Sponsor
ProTiP Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01587664
Brief Title
NewBreez Safety and Efficacy Evaluation
Official Title
Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to lack of recruitment and loss of the French principal investigator.
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProTiP Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Disorders
Keywords
Swallowing disorders, Aspiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NewBreez ILP
Arm Type
Experimental
Arm Description
Implantation of a NewBreez ILP
Intervention Type
Device
Intervention Name(s)
NewBreez ILP
Intervention Description
NewBreez ILP implantation
Primary Outcome Measure Information:
Title
Aspiration score at 1 month
Description
Within-subject relative change-from-baseline at 1 month in aspiration score based on radiographic swallowing study
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Remacle, Prof.
Organizational Affiliation
UCL Mont-Godinne (Belgium)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

NewBreez Safety and Efficacy Evaluation

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