NCT03466879

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Tivic Health Systems · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

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-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.

Conditions

• Sinus; Inflammation

Interventions

Type	Name	Description
DEVICE	SYNUS Pain Relief device	SYNUS Pain Relief is a handheld micro-current TENS device used for the temporary relief of sinus pain.

Timeline

• Start date: 2018-02-02
• Primary completion: 2018-07-21
• Completion: 2018-07-21
• First posted: 2018-03-15
• Last updated: 2018-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study