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

Sinus; Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466879
• Other study ID #: CP00001
• Status: Completed
• Start date: February 2, 2018
• Est. completion date: July 21, 2018

Study information

• Verified date: December 2018
• Source: Tivic Health Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 21, 2018
• Est. primary completion date: July 21, 2018
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Sinus; Inflammation
• Sinusitis

Intervention

Device:
• SYNUS Pain Relief device
SYNUS Pain Relief is a handheld micro-current TENS device used for the temporary relief of sinus pain.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Tivic Health Systems	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	Average decrease in pain score of the SYNUS device is greater than the average decrease is pain score for the sham/placebo device.	10 minutes