NewBreez Safety and Efficacy Evaluation

Not Applicable

Terminated

• Conditions: Swallowing Disorders
• Interventions: Device: NewBreez ILP

• Registration Number: NCT01587664
• Lead Sponsor: ProTiP Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Study Start: 2012-05
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NewBreez ILP	NewBreez ILP	Implantation of a NewBreez ILP

Primary Outcome Measures

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

Trial Locations

Locations (2)

CHU Mont-Godinne; 🇧🇪 Yvoir, Belgium

Hopital Avicenne; 🇫🇷 Bobigny, France