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

Tivic Health Systems

Status

Completed

Conditions

Sinus; Inflammation

Treatments

Device: SYNUS Pain Relief device

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03466879

CP00001

Details and patient eligibility

About

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.

Full 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-currents to stimulate major nerve fibers passing from the sinus passages through various foramina to the facial skin. Subjects will read manufacturer's provided Instructions-For-Use (IFU's) and without help from staff will proceed to self-perform the treatment. The other subjects will follow the same procedure but use a sham/placebo device with no stimulating current. Subjects will be blinded as to the device they use. Prior to and 10 minutes following the stimulation, subjects will score their pain level on a visual analogue scale.

Enrollment

72 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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