Research

Tivic Health’s Products are Grounded in Science

  • Evidence-based and evaluated with rigorous methods
  • Thoroughly tested and designed to meet medical device standards and FDA scrutiny
  • Committed to innovation with modern, well-designed, safe and effective medical devices that improve consumer’s quality of life

 

How does the ClearUP® Sinus Pain Relief device work?

  • Microcurrent is emitted as ClearUP device glides along cheek, nose, brow bone.
  • Electrical stimulation of nerves under the skin reduces feelings of pressure and pain for up to 6 hours
  • Electrical stimulation can also shrink swollen tissue – swelling is often a key cause of nasal and sinus symptoms
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Glide device along cheek, nose, brow bone.

Microcurrent Clinical Trials Conducted on ClearUP® Device

First trial1: participants using ClearUP vs. a sham treatment reported significant improvement in sinus pain

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Second trial2: subjects received 5-minute treatment in office, followed by 4 weeks of at-home use also saw marked improvements

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1 At Stanford Sinus Center, Palo Alto, Calif. | Publication: Maul, X.A., Borchard, N.A., Hwang, P.H., and Nayak, J.V. (2019, April). Microcurrent technology for rapid relief of sinus pain: a randomized placebo-controlled, double-blinded clinical trial in International Forum of Allergy and Rhinology (IFAR) (Vol. 9, No. 4, Pp. 352-356)| Principal investigator: Jayakar Nayak, MD, PhD, Associate Professor and Director of Rhinology Research, Stanford University

2 At Allergy and Asthma Associates of Santa Clara Valley Research Center, Santa Clara, Calif.|Publication: In preparation for peer review|Principal investigator: Alan Goldsobel, MD, Adjunct Associate Professor, Stanford University.

 

Published Clinical Studies

JOURNAL PUBLICATION: BIOELECTRONIC MEDICINE: PROSPECTIVE TRIAL EXAMINING SAFETY AND EFFICACY OF MICROCURRENT STIMULATION FOR THE TREATMENT OF SINUS PAIN AND CONGESTION. ALAN B. GOLDSOBEL1,2,3, NIVEDITHA PRABHAKAR2 AND BLAKE T. GURFEIN 3,4* 2019

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Journal Publication: Microcurrent technology for rapid relief of sinus pain: a randomized, placebo controlled, double-blinded clinical trial. Ximena A. Maul, MD1,2,*, Nicole A. Borchard1,*, Jayakar V. Nayak, MD, PhD1. 2019

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Abstract: Microcurrent technology for rapid relief of sinus pain: A randomized, placebo controlled, double-blinded clinical trial. Oct 2018

Microcurrent technology for rapid relief of sinus pain: A randomized, placebo controlled, double-blinded clinical trial.

Ximena A. Maul, MD1,2, Nicole A. Borchard1, Peter H. Hwang, MD1, *, Jayakar V. Nayak, MD, PhD1
1Division of Rhinology, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, CA; 2Department of Otolaryngology, Pontificia Universidad Católica of Chile School of Medicine, Santiago, Chile.
*Is a member of the SAB of the sponsor
Tivic Health Systems, Inc. sponsored this clinical trial

Introduction: Transcutaneous electrical nerve stimulation has proven to be effective in alleviating chronic pain from facial myalgias. We evaluated the efficacy of a novel, handheld microcurrent-emitting device in the short-term, office-based treatment of patients with complaints of sinus pain.

Methods: Seventy-one participants with facial pain related to self-reported nasal/sinus disease were recruited from a tertiary rhinologic practice and the surrounding community and randomly assigned to office-based use of an active (n=38) or sham (n=33) handheld microcurrent emitter. The study device (not yet FDA-cleared), which automatically activates in regions corresponding to nerve fibers, was repetitively applied by the patient to the bilateral periorbital areas for five minutes. Visual analogue scale for pain was collected before, and 10 minutes after, treatment.

Results: Active microcurrent-treated patients had a mean pain score reduction from 5.63 pre-treatment to 3.97 post-treatment (mean difference, 1.66; CI95, 1.20-2.12). Patients using the sham device also reported sinus pain reductions representing placebo effect (mean difference, 0.91; CI95, 0.61-1.21). However, the active device demonstrated a significantly greater reduction in pain compared to sham (0.75 point difference, p=0.007). Notably, 22.5% of patients using the active device had a reduction of 3 points or more compared to 0% of sham device patients (p=0.003). One minor complication of transient facial skin erythema was noted.

Conclusion: This randomized, double-blinded, placebo-controlled trial suggests that treatment of rhinologic facial pain using this non-invasive microcurrent device is safe and effective in providing rapid relief of nasal/sinus pain complaints. Additional studies with longer term follow-up are warranted.

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