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Other
Active device users for Sinusitis
N/A
Waitlist Available
Led By Jayakar Nayak, MD
Research Sponsored by Tivic Health Systems
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Sinusitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain reduction
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sham device usersExperimental Treatment0 Interventions
Users will use a sham SYNUS Pain Relief device that is not providing treatment
Group II: Active device usersExperimental Treatment1 Intervention
Users will use an active SYNUS Pain Relief device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SYNUS Pain Relief device
2018
N/A
~80
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Who is running the clinical trial?
Tivic Health SystemsLead Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Sinusitis
60 Patients Enrolled for Sinusitis
Stanford UniversityOTHER
2,471 Previous Clinical Trials
17,501,926 Total Patients Enrolled
4 Trials studying Sinusitis
239 Patients Enrolled for Sinusitis
Jayakar Nayak, MDPrincipal InvestigatorStanford University
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