Status:
COMPLETED
A User Study of SYNUS Pain Relief Made by Tivic Health Systems
Lead Sponsor:
Tivic Health Systems
Collaborating Sponsors:
Stanford University
Conditions:
Sinus; Inflammation
Eligibility:
All Genders
18-99 years
Brief Summary
Demonstrate the ability of subjects suffering from sinus pain to self-treat with the SYNUS Pain Relief device and to obtain pain relief compared to a sham/placebo device.
Detailed Description
A prospective study of at least 58 recruited subjects suffering from sinus pain. At least 30 of the subjects will be randomly selected to use the SYNUS Pain Relief device, a device that uses micro-cur...
Eligibility Criteria
Inclusion
- Be 18 years of age and older
- Present with symptoms of sinus pain and pressure
- Have an initial sinus pain score of 4 or more on the visual analogue scale
- Be able to read and understand English
- Agree to participate in the study
- Be able and willing to provide Informed Consent
Exclusion
- Do not meet Inclusion Criteria
- Have currently a dental infection
- Have currently abnormal cranial nerve or other neurological findings or symptoms that would require prompt medical attention
- Be currently pregnant
- Have implanted electrostimulation devices including a pacemaker, a DBS or a cochlear implant
Key Trial Info
Start Date :
February 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 21 2018
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03466879
Start Date
February 2 2018
End Date
July 21 2018
Last Update
December 26 2018
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94306