Sinus; InflammationNCT03466879
A User Study of SYNUS Pain Relief Made by Tivic Health Systems
An observational study of Sinus; Inflammation, run by Tivic Health Systems at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sinus; Inflammation
- What is being tested?
- SYNUS Pain Relief device
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2018to 21 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: At least 58 subjects suffering from sinus pain
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- SYNUS Pain Relief device
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNUS Pain Relief deviceDevice
SYNUS Pain Relief is a handheld micro-current TENS device used for the temporary relief of sinus pain.
| Study group | Role | What they receive |
|---|---|---|
| Active device users | Users will use an active SYNUS Pain Relief device Receives: Device: SYNUS Pain Relief device | |
| Sham device users | Users will use a sham SYNUS Pain Relief device that is not providing treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start2 Feb 2018
- Primary completion21 Jul 2018
- Study completion21 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus; InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tivic Health Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Jayakar Nayak, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466879
- Sponsor's protocol ID
- CP00001
- Status last verified
- Dec 2018
- First submitted
- 9 Mar 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A User Study of SYNUS Pain Relief Made by Tivic Health Systems
- ClinicalTrials.gov ID
- NCT03466879
- Acronym / sponsor ID
- CP00001
- Conditions
- Sinus; Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tivic Health SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 21 Jul 2018 (actual)
- Study completion
- 21 Jul 2018 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active device users | – | Device: SYNUS Pain Relief deviceUsers will use an active SYNUS Pain Relief device |
| Sham device users | – | –Users will use a sham SYNUS Pain Relief device that is not providing treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- At least 58 subjects suffering from sinus pain
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYNUS Pain Relief deviceSYNUS Pain Relief is a handheld micro-current TENS device used for the temporary relief of sinus pain. | Device | Active device users |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayakar Nayak, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinus; Inflammation, run by Tivic Health Systems at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.