Using a device to reduce bleeding during sinus surgery
Auricular Neuromodulation and Surgical Conditions During Functional Endoscopic Sinus Surgery
This study is testing if a device that stimulates a nerve can help reduce bleeding during sinus surgery to make the procedure easier and safer for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06662422 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of cutaneous vagal nerve stimulation on surgical conditions for patients undergoing functional endoscopic sinus surgery (FESS). Participants will be randomly assigned to receive either active stimulation or a sham treatment using the Spark Biomedical Sparrow Ascent Transcutaneous Auricular Neurostimulation system. The device aims to decrease intraoperative bleeding, thereby improving visibility for surgeons and potentially enhancing surgical outcomes. The study will assess both the efficacy and safety of this innovative approach in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates are patients classified as ASA 1 and 2 who are scheduled for elective FESS surgery.
Not a fit: Patients with coagulation disorders, recent blood transfusions, or those who cannot use the device due to anatomical issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for patients undergoing sinus surgery.
How similar studies have performed: Previous studies have shown success with similar neuromodulation approaches in other surgical contexts, suggesting potential for this application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Katz, MD — Mount Sinai Hospital
- Study coordinator: Daniel Katz, MD
- Email: daniel.katz@mountsinai.org
- Phone: (212) 241-7475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.