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

NCT ID: NCT03466879

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-02

Study Completion Date

2018-07-21

Brief Summary

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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

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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

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Sinus; Inflammation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Active device users

Users will use an active SYNUS Pain Relief device

SYNUS Pain Relief device

Intervention Type DEVICE

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

Sham device users

Users will use a sham SYNUS Pain Relief device that is not providing treatment

No interventions assigned to this group

Interventions

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SYNUS Pain Relief device

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

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

Tivic Health Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayakar Nayak, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP00001

Identifier Type: -

Identifier Source: org_study_id