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NCT06662422 · ClinicalTrials.gov registry record · NA
Auricular Neuromodulation for FESS
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT06662422: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06662422 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06662422, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DEVICE Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-10-23 |
| Est. Completion | 2025-06-18 |
| Phase | NA |
What the finished NCT06662422 record still lists
NCT06662422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System is the first listed.
NCT06662422 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06662422 about?
NCT06662422 is a clinical study titled "Auricular Neuromodulation for FESS". 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...
What is the current status of trial NCT06662422?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2024-10-23. Estimated completion is 2025-06-18.
What interventions are being tested in trial NCT06662422?
The interventions under investigation include: Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) System (DEVICE).
Who is sponsoring clinical trial NCT06662422?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06662422's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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