NewBreez Safety and Efficacy Evaluation

ProTiP Medical

Status: Terminated

Conditions: Swallowing Disorders

Treatments: Device: NewBreez ILP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01587664

PIL-02-PEC-1-A

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

NewBreez ILP

Experimental group

Description:

Implantation of a NewBreez ILP

Treatment:

Device: NewBreez ILP