Auricular Neuromodulation for FESS

NCT06662422 | Completed FDA Device

• 1 other identifier: STUDY-24-00047
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

blood loss; postoperative pain; Functional Endoscopic Sinus Surgery; Vagal Nerve Stimulation; Platelet Activation

Outcome Measures

Primary Outcomes (1)

• Boezaart Score

  Perioperative bleeding by Boezaart Score. Full scale is graded from Grade of 0 (clear surgical field) to 5 (severe bleeding). Higher score indicates more severe bleeding.

  every 15 minutes during surgical procedure

Secondary Outcomes (3)

• Post-operative nausea score

  during PACU stay, average PACU stay is 3 hours

• Post-operative vomiting score

  during PACU stay, average PACU stay is 3 hours

• Visual Analog Scale (VAS) for Post-operative pain score

  30 minutes after procedure

Study Arms (2)

Electrostimulation

EXPERIMENTAL

Device will be turned on to send electrostimulation.

Device: Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System

Sham - no electrostimulation

SHAM COMPARATOR

Device will be toggled to Sham so no electrostimulation will be given.

Device: Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System

Interventions

Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System DEVICE

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).

Electrostimulation; Sham - no electrostimulation

Eligibility Criteria

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

You may qualify if:

• ASA 1 and 2
• Presenting for elective FESS surgery

You may not qualify if:

• Anti-fibrinolytic use within 30 days of enrollment
• Known or acquired coagulation disorders
• Hypercoagulable state, including morbid obesity and active smoking
• Pregnancy
• Blood transfusion with 30 days of enrollment
• History of epileptic seizures
• Presence of device such as pacemaker, cochlear prosthesis, neurostimulator
• Ear infection
• Abnormal ear anatomy which inhibits application of device
• Presence of other significant disease or disorder which under the discretion of the principal investigator could influence the results of the trial or the participant's ability to participate in the trial

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Hemorrhage; Pain, Postoperative

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Daniel Katz, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: October 23, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)