Functional Endoscopic Sinus SurgeryNCT06662422
Auricular Neuromodulation for FESS
A study testing Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System in people with Functional Endoscopic Sinus Surgery and Vagal Nerve Stimulation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Endoscopic Sinus Surgery, Vagal Nerve Stimulation, Platelet Activation
- What is being tested?
- Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2024to 18 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 and 2
- Presenting for elective FESS surgery
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System
- Keywords
- blood loss, postoperative pain, Functional Endoscopic Sinus Surgery, Vagal Nerve Stimulation, Platelet Activation
- Medical subject headings
- Hemorrhage, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Electrostimulation | Experimental | Device will be turned on to send electrostimulation. Receives: 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. Receives: Device: Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boezaart Score
Weighted average of perioperative bleeding by Boezaart Score measured every 15 minutes during surgical procedure Full scale is graded from Grade of 0 (clear surgical field) to 5 (severe bleeding). Higher score indicates more severe bleeding.
Measured: every 15 minutes during surgical procedure
Secondary outcomes (3)
Number of Participants With Post-operative Nausea
Nausea measured by presence/absence at any time during Post Anesthesia Care Unit (PACU) stay following surgical procedure
Measured: during PACU stay, average PACU stay is 3 hours
Number of Participants With Post-operative Vomiting
Vomiting measured by presence/absence at any time during PACU stay following surgical procedure
Measured: 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.
Measured: 30 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start23 Oct 2024
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional Endoscopic Sinus SurgeryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniel Katz, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662422
- Sponsor's protocol ID
- STUDY-24-00047
- Status last verified
- Jun 2025
- First submitted
- 25 Oct 2024
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data and/or samples will only be used to complete this study and then they will be destroyed.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Neuromodulation and Surgical Conditions During Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT06662422
- Acronym / sponsor ID
- STUDY-24-00047
- Keywords
- blood loss, postoperative pain, Functional Endoscopic Sinus Surgery, Vagal Nerve Stimulation, Platelet Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Posted 19 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrostimulation | Experimental | Device: Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) SystemDevice will be turned on to send electrostimulation. |
| Sham - no electrostimulation | Sham comparator | Device: Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) SystemDevice will be toggled to Sham so no electrostimulation will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1 and 2
- Presenting for elective FESS surgery
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) SystemThe 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). | Device | Electrostimulation, Sham - no electrostimulation |
Primary outcome
Boezaart Score
Time frame: every 15 minutes during surgical procedure
Weighted average of perioperative bleeding by Boezaart Score measured every 15 minutes during surgical procedure Full scale is graded from Grade of 0 (clear surgical field) to 5 (severe bleeding). Higher score indicates more severe bleeding.
3 secondary outcomes
Number of Participants With Post-operative Nausea
Time frame: during PACU stay, average PACU stay is 3 hours
Number of Participants With Post-operative Vomiting
Time frame: during PACU stay, average PACU stay is 3 hours
Visual Analog Scale (VAS) for Post-operative Pain Score
Time frame: 30 minutes after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data and/or samples will only be used to complete this study and then they will be destroyed.
Related trials for Functional Endoscopic Sinus Surgery
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Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
RecruitingObservational study
Opioid-Free Anesthesia in FESS: A Prospective ERAS Study
Chronic Sinusitis, Postoperative Pain
Not yet recruiting
Preoperative Ivabradine Doses for Hemodynamic Stability in FESS
Hemodynamic Instability
Enrolling by invitationPhase 1
Preoperative Nebulized Dexmedetomidine Versus Nebulized Magnesium Sulphate in Reducing Emergence Agitation in FESS
Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Katz, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System in people with Functional Endoscopic Sinus Surgery and Vagal Nerve Stimulation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boezaart Score (time frame: every 15 minutes during surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.