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Auricular Neuromodulation for FESS

NCT06662422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Functional Endoscopic Sinus Surgery
  • Vagal Nerve Stimulation
  • Platelet Activation

Interventions

DEVICE

Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System

The Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System is a single-use electrode placed on and around the ear which provides transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN).

Sponsors & Collaborators

Principal Investigators

  • Daniel Katz, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2025-06-18
Completion
2025-06-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06662422 on ClinicalTrials.gov