NewBreez Safety and Efficacy Evaluation

Swallowing Disorders Clinical Trial

Official title:

Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01587664
• Other study ID #: PIL-02-PEC-1-A
• Status: Terminated
• Phase: N/A
• First received: April 26, 2012
• Last updated: April 7, 2017
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: ProTiP Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Swallowing Disorders

Intervention

Device:
• NewBreez ILP
NewBreez ILP implantation

Locations

Country	Name	City	State
Belgium	CHU Mont-Godinne	Yvoir
France	Hopital Avicenne	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
ProTiP Medical

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspiration score at 1 month	Within-subject relative change-from-baseline at 1 month in aspiration score based on radiographic swallowing study	1 month