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Clinical Trials/NCT01587664
NCT01587664TerminatedNot Applicable

Safety and Efficacy Evaluation of the NewBreez Intra-laryngeal Prosthesis

ProTiP Medical2 sites in 2 countries2 target enrollmentStarted: May 1, 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
2
Locations
2
Primary Endpoint
Aspiration score at 1 month
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

NewBreez ILP

Experimental

Implantation of a NewBreez ILP

Intervention: NewBreez ILP (Device)

Outcomes

Primary Outcomes

Aspiration score at 1 month

Time Frame: 1 month

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
ProTiP Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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