Auricular Neuromodulation for FESS

Auricular Neuromodulation and Surgical Conditions During Functional Endoscopic Sinus Surgery

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.

Study Overview

• Status: Completed
• Conditions: Platelet Activation; Functional Endoscopic Sinus Surgery; Vagal Nerve Stimulation
• Intervention / Treatment: Device: Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System

Detailed Description

Functional endoscopic sinus surgery is an important procedure for controlling a variety of sinus disease. Given the proximity to the brain and vascularity of tissues, good visualization is paramount. Intraoperative bleeding and obscure the view of the surgeon. In this study, the investigators will use a neuromodulation device that will decrease bleeding and lead to better surgical conditions during the surgery. The device used has already been studied in other bleeding environments. The investigators believe it will also work for this case. The study on Functional Endoscopic Sinus Surgery (FESS) will focus on the use of an innovative device designed to control bleeding and enhance visualization during surgery. FESS, a critical procedure for treating sinus-related conditions, often faces challenges related to bleeding and poor visibility, impacting surgical outcomes. This study aims to address these challenges by introducing a device used in other areas that promises to revolutionize the standard procedure. The device for the study, the Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System, should decrease bleeding, a common obstacle in sinus surgery. This not only improves visibility for the surgeon but is also expected to lead to more accurate surgical interventions, reduced operation times, and fewer complications. The study will explore the efficacy and safety of this device, making a significant contribution to the field of sinus surgery and medical technology. This technology has been used in other areas, namely opiate use disorder, for which it has an FDA approval. The investigators plan to conduct a detailed investigation into the device's performance, employing a methodology that may include randomized controlled trials, adequate sample sizes, and comprehensive data collection methods. The study will assess various parameters such as the effectiveness of bleeding control, the impact on surgical duration, and overall patient outcomes. This research is not only significant for its potential to improve surgical techniques but also for its broader implications in patient care and medical innovation. By testing the hypotheses related to the device's performance and expected outcomes, the study aims to provide valuable insights that could transform the practice of sinus surgery, enhancing patient safety and surgical efficiency.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA 1 and 2
• Presenting for elective FESS surgery

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electrostimulation; Device will be turned on to send electrostimulation.	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).
Sham Comparator: Sham - no electrostimulation; Device will be toggled to Sham so no electrostimulation will be given.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative nausea score	Nausea measured by presence/absence at any time during Post Anesthesia Care Unit (PACU) stay following surgical procedure	during PACU stay, average PACU stay is 3 hours
Post-operative vomiting score	Vomiting measured by presence/absence at any time during PACU stay following surgical procedure	during PACU stay, average PACU stay is 3 hours
Visual Analog Scale (VAS) for Post-operative pain score	Pain score at initial assessment in PACU before pain medication given, once patient in alert and oriented, at approximately 30 minutes after end of surgery, measured by VAS. Full scale from 0 to 10, higher score indicates more pain.	30 minutes after procedure

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Daniel Katz, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): June 18, 2025

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: blood loss; postoperative pain; Platelet Activation; Functional Endoscopic Sinus Surgery; Vagal Nerve Stimulation
• Other Study ID Numbers: STUDY-24-00047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data and/or samples will only be used to complete this study and then they will be destroyed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No