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

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ClinicalTrials.gov Identifier: NCT03466879
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Tivic Health Systems

Brief 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.

Condition or disease Intervention/treatment
Sinus; Inflammation Device: SYNUS Pain Relief 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.

Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A User Study of SYNUS Pain Relief Made by Tivic Health Systems
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
At least 58 subjects suffering from sinus pain
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466879


Contacts
Contact: Nina Peled, PhD 650 454 0322 npeled@yahoo.com

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94306
Contact: Ximena Maul Fonseca, MD       ximemaul@stanford.edu   
Contact: Jayakar Nayak, MD       jnayak@stanford.edu   
Sponsors and Collaborators
Tivic Health Systems
Stanford University
Investigators
Principal Investigator: Jayakar Nayak, MD Stanford University

Responsible Party: Tivic Health Systems
ClinicalTrials.gov Identifier: NCT03466879     History of Changes
Other Study ID Numbers: CP00001
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Inflammation
Sinusitis
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases