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NCT06662422

Auricular Neuromodulation for FESS

Completed NA Last updated 2 July 2025
What this trial tests

NA trial testing Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System in Functional Endoscopic Sinus Surgery in 20 participants. Completed in 18 June 2025.

Timeline
23 October 2024
Primary endpoint
18 June 2025
18 June 2025

Quick facts

Lead sponsorIcahn School of Medicine at Mount Sinai
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment20
Start date23 October 2024
Primary completion18 June 2025
Estimated completion18 June 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Functional Endoscopic Sinus Surgery or Vagal Nerve Stimulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this blinded prospective randomized control trial the researchers will investigate the impact of cutaneous vagal nerve stimulation on surgical conditions in patients undergoing functional and ascorbic sinus surgery (FESS). The device is an externally placed vagal nerve stimulator. The device will be applied to participants after consent and induction of anesthesia. The study team will open the randomization envelope and if the participant is assigned to stimulation the device will be turned on. In the case that the participant is assigned to the control arm, the device will be set to sham. The device will remain on for 30 minutes and removed before entering the OR. Device will be reinserted in the recovery room for another 30 minutes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Functional Endoscopic Sinus Surgery

Currently open trials in the same condition.

Other Icahn School of Medicine at Mount Sinai trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT06662422.

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