Laryngeal Pacing Study

NCT03085316 | Terminated FDA Device

• 1 other identifier: 141242
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

Standard treatment options for patients who are diagnosed with BVFP include tracheostomy, cordotomy, arytenoidectomy, and suture tie-back. These standard treatment options may result in permanent damage to the vocal fold, therefore affecting the patient's ability to speak and compromising airway protection during swallowing. Additionally, these routine procedures cannot provide sufficient airway to permit significant aerobic activity. The goal in conducting this early feasibility study is to investigate the use of this device as a laryngeal pacemaker to treat BVFP.

Conditions

Bilateral Vocal Fold Paralysis (BVFP)

Outcome Measures

Primary Outcomes (1)

• Demonstration of a consistent surgical approach with successful implantation and functionality of a laryngeal pacemaker, as indicated by the presence of stimulated motion of the chronically paralyzed vocal fold.

  12 to 15 months

Secondary Outcomes (3)

• Increased glottal area due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.

  12 to 15 months

• Increased ventilation due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.

  12 to 15 months

• Minimal impairment of voice due to laryngeal pacemaker stimulation as assessed by increase in standard assessment testing.

  12 to 15 months

Study Arms (1)

Investigational Device

EXPERIMENTAL

Patient who meets eligibility to be implanted with the St. Jude Medical Infinity™ Implantable Pulse Generator System (P140049), St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) Directional Lead and Extension (P140009), Swift-Lock™ Anchor (K092371), Butterfly anchor (P140009), manufactured by St. Jude Medical, Inc.

Device: Investigational device

Interventions

Investigational device DEVICE

Device is an implantable neurostimulation system designed to deliver low-intensity electrical impulses to nerve structures.

Also known as: St. Jude Medical Infinity™ Implantable Pulse Generator System (P140049), Deep Brain Stimulation (DBS) Directional Lead and Extension (P140009), Swift-Lock™ Anchor (K092371), Butterfly anchor (P140009)

Investigational Device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult patients, 22 years of age or older
• Diagnosis of bilateral vocal fold paralysis, at least one year prior to study enrollment
• Must have tracheostomy in place minimum of 6 weeks prior to implantation of St.Jude Medical Infinity™ IPG device
• Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles
• Demonstrated peak inspiratory flow with respiratory testing through the mouth of at least 0.4 L/sec

You may not qualify if:

• Any active illness that is associated with an immune disorder (such as diabetes)
• History of cardiac dysrhythmias or implanted cardiac pacemaker
• Any electronic implanted medical device that, in the investigator's opinion, could interact with the laryngeal pacemaker
• Active cardiac disease manifested by unstable angina, recent myocardial infarction, malignant arrhythmias, uncontrolled hypertension (diastolic greater than 110), or decompensated congestive heart failure
• Patients with underlying comorbidities that, in the investigator's opinion, could potentially warrant a need for oxygen therapy, including but not limited to: Chronic obstructive pulmonary disease, asthma, emphysema, recurrent bronchitis, pneumonia or interstitial lung disease
• Bilateral laryngeal immobility from stenosis or arthritis
• Poor Surgical risk patients as determined by the treating surgeon or Vanderbilt Preoperative Evaluation Center (VPEC)
• Patients with acute or chronic infections
• The abundance of interstitial fat may impede the surgical dissection. In the opinion of the principal investigator or treating physician(s), patients with factors that may complicate the surgical intervention will be excluded.
• Known allergy to barium dye or anesthetics
• Known allergy to any of the device materials
• Patients who in the opinion of the investigator, based on needle stimulation testing, have insufficient PCA muscle mass to implant leads
• Patients with pre-existing liquid dysphagia
• Presence of significant tracheal narrowing
• Any anatomical abnormality that would jeopardize safe implantation, per the treating surgeon

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Abbott Medical Devices: collaborator

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• David L. Zealear, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Otolaryngology

Model Details: All patients who meet eligibility will undergo device implantation surgery and follow up per protocol.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 21, 2017
• Study Start: October 26, 2015
• Primary Completion: July 19, 2023
• Study Completion: November 7, 2023
• Last Updated: February 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share