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NCT06662422
Auricular Neuromodulation for FESS
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.
18 June 2025
Quick facts
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 20 |
| Start date | 23 October 2024 |
| Primary completion | 18 June 2025 |
| Estimated completion | 18 June 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System
Conditions studied
- Functional Endoscopic Sinus Surgery — all drugs for Functional Endoscopic Sinus Surgery →
- Vagal Nerve Stimulation — all drugs for Vagal Nerve Stimulation →
- Platelet Activation — all drugs for Platelet Activation →
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:
- PubMed search for NCT06662422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Functional Endoscopic Sinus Surgery
Currently open trials in the same condition.
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Other Icahn School of Medicine at Mount Sinai trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06662422 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
- Last refreshed: 2 July 2025
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