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

December 21, 2018 updated by: Tivic Health Systems
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94306
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

At least 58 subjects suffering from sinus pain

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active device users
Users will use an active SYNUS Pain Relief device
Device: SYNUS Pain Relief 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction
Time Frame: 10 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tivic Health Systems

Collaborators

Stanford University

Investigators

  • Principal Investigator: Jayakar Nayak, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2018

Primary Completion (Actual)

July 21, 2018

Study Completion (Actual)

July 21, 2018

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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