Status:
COMPLETED
Microcurrent Device (TIVIC Health)
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Tivic Health Systems
Conditions:
Chronic Rhinosinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease...
Eligibility Criteria
Inclusion
- Scheduled for FESS functional nasal or endoscopic sinus surgery
- Possessing an American Society of Anesthesiologists physical status classification of I or II
- Age ≥ 18
- Possess the capacity to give informed consent
- Able to read, write and understand English or Spanish
- Able to attend follow up visits at postop days 7 and 14 Visit 1 (within 0 - day 14) and post-op Visit 2 (within 10 - 21 days)
- Postop pain VAS ≥ 5 in PACU phase II
Exclusion
- Age \< 18
- Does not understand English or Spanish
- Does not meet inclusion criteria
- History of chronic pain
- Experiencing chronic pain requiring opioids at baseline and/or who are under the care of pain management specialists
- Neurologic disorders (including seizure disorders)
- Undergoing planned or unplanned additional procedures at the time of FESS surgery
- In custody of the state
- Prisoners
- Known to be pregnant
- Implanted cranial metallic components or devices including deep brain stimulators or cochlear implants
- Has an implanted or external worn cardiac device including pacemakers, automated implantable cardioverter defibrillator (AICD), or any other cardiac electric devices (including non-implanted devices, e.g. defibrillator vest)
Key Trial Info
Start Date :
March 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05198518
Start Date
March 30 2022
End Date
April 4 2024
Last Update
June 12 2025
Active Locations (1)
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1
Faculty Practice Associates - Mount Sinai Doctors
New York, New York, United States, 10028