A User Study of SYNUS Pain Relief Made by Tivic Health Systems

Completed

Conditions studied: Sinus; Inflammation

In brief

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.

Key facts

Study ID

NCT03466879

Run by

Tivic Health Systems

People needed

72

Starts

2018-02-02

Expected to finish

2018-07-21

Last updated by the study team

2018-12-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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