Who is sponsoring NCT03085316?

NCT03085316 is sponsored by Vanderbilt University Medical Center.

What drugs are being tested in NCT03085316?

Interventions in NCT03085316: Investigational device.

What condition does NCT03085316 study?

NCT03085316 studies Bilateral Vocal Fold Paralysis (BVFP).

Is NCT03085316 still recruiting?

NCT03085316 is currently terminated. Last updated 28 February 2025.

Last reviewed 2025-02-28 · How we verify

NCT03085316: BVFP IDE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Laryngeal Pacing Study

Terminated NA Last updated 28 February 2025

What this trial tests

NA trial testing Investigational device in Bilateral Vocal Fold Paralysis (BVFP) in 2 participants. Terminated before completion.

Timeline

26 October 2015

Primary endpoint
19 July 2023

7 November 2023

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	2
Start date	26 October 2015
Primary completion	19 July 2023
Estimated completion	7 November 2023

Drugs / interventions tested

Investigational device

Conditions studied

Bilateral Vocal Fold Paralysis (BVFP) — all drugs for Bilateral Vocal Fold Paralysis (BVFP) →

Sponsor

Vanderbilt University Medical Center

Who can join

22 and older, any sex, with Bilateral Vocal Fold Paralysis (BVFP). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Unilateral and Bilateral Laryngeal Pacing for Bilateral Vocal Fold Paralysis.
Powell ME, Zealear DL, Li Y, Garrett CG, et al · · 2020 · cited 5× · PMID 34084663 · DOI 10.1007/s40136-020-00313-7
Functional Results of Surgical Treatment of Bilateral Lesions of the Recurrent Laryngeal Nerve.
Jovic R, Samac Tovilovic K, Dragicevic D, Gasic J, et al · · 2025 · PMID 41018332 · DOI 10.7759/cureus.91043

Verify or expand the search:

Other trials of Investigational device

Trials testing the same drug.

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Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

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NCT07295288 — Botox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis · Phase 4 · not yet recruiting
NCT07431541 — Topical Carboxytherapy Paste Following Microneedling · Phase 1, PHASE2 · not yet recruiting
NCT07224711 — The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery · Phase 4 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03085316 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
Last refreshed: 28 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03085316.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing