Trial Outcomes & Findings for Auricular Neuromodulation for FESS (NCT NCT06662422)
NCT ID: NCT06662422
Last Updated: 2026-08-19
Results Overview
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.
COMPLETED
NA
20 participants
every 15 minutes during surgical procedure
2026-08-19
Participant Flow
Participant milestones
| Measure |
Electrostimulation
Device will be turned on to send electrostimulation.
|
Sham - no Electrostimulation
Device will be toggled to Sham so no electrostimulation will be given.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auricular Neuromodulation for FESS
Baseline characteristics by cohort
| Measure |
Electrostimulation
n=9 Participants
Device will be turned on to send electrostimulation.
|
Sham - no Electrostimulation
n=11 Participants
Device will be toggled to Sham so no electrostimulation will be given.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 15.98 • n=298 Participants
|
34.27 years
STANDARD_DEVIATION 7.80 • n=102 Participants
|
38.65 years
STANDARD_DEVIATION 12.82 • n=400 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=298 Participants
|
5 Participants
n=102 Participants
|
8 Participants
n=400 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=298 Participants
|
6 Participants
n=102 Participants
|
12 Participants
n=400 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
2 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=400 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=298 Participants
|
8 Participants
n=102 Participants
|
15 Participants
n=400 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=400 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=298 Participants
|
11 Participants
n=102 Participants
|
19 Participants
n=400 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
PRIMARY outcome
Timeframe: every 15 minutes during surgical procedureWeighted 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.
Outcome measures
| Measure |
Electrostimulation
n=9 Participants
Device will be turned on to send electrostimulation.
|
Sham - no Electrostimulation
n=11 Participants
Device will be toggled to Sham so no electrostimulation will be given.
|
|---|---|---|
|
Boezaart Score
|
1.76 score on a scale
Standard Deviation 0.56
|
1.52 score on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: during PACU stay, average PACU stay is 3 hoursNausea measured by presence/absence at any time during Post Anesthesia Care Unit (PACU) stay following surgical procedure
Outcome measures
| Measure |
Electrostimulation
n=9 Participants
Device will be turned on to send electrostimulation.
|
Sham - no Electrostimulation
n=11 Participants
Device will be toggled to Sham so no electrostimulation will be given.
|
|---|---|---|
|
Number of Participants With Post-operative Nausea
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: during PACU stay, average PACU stay is 3 hoursVomiting measured by presence/absence at any time during PACU stay following surgical procedure
Outcome measures
| Measure |
Electrostimulation
n=9 Participants
Device will be turned on to send electrostimulation.
|
Sham - no Electrostimulation
n=11 Participants
Device will be toggled to Sham so no electrostimulation will be given.
|
|---|---|---|
|
Number of Participants With Post-operative Vomiting
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 minutes after procedurePain 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.
Outcome measures
| Measure |
Electrostimulation
n=9 Participants
Device will be turned on to send electrostimulation.
|
Sham - no Electrostimulation
n=11 Participants
Device will be toggled to Sham so no electrostimulation will be given.
|
|---|---|---|
|
Visual Analog Scale (VAS) for Post-operative Pain Score
|
4.5 score on a scale
Standard Deviation 13.41
|
5.91 score on a scale
Standard Deviation 2.91
|
Adverse Events
Electrostimulation
Sham - no Electrostimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Daniel Katz
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place