Clinical Study: A User Study of ClearUP Sinus Pain Relief, a device developed by Tivic Health Systems Inc

Clinical Study: A User Study of ClearUP Sinus Pain Relief, a device developed by Tivic Health Systems Inc

August 31, 2018

Study Site: Stanford Sinus Center, Stanford University Medical School

Principal Investigator: Jayakar Nayak, MD, PhD, Associate Professor and Director of Rhinology Research, Stanford University

Study Design: Seventy-one participants with self-reported sinus pain were recruited from a rhinology practice and from the surrounding community and were randomly assigned to office-based use of an active (n=38) or sham (n=33) handheld ClearUPTM Sinus Pain Relief microcurrent device. The ClearUP device, which automatically activates in regions of low impedance, was repetitively applied by the patient to the bilateral periorbital areas for five minutes. Visual analogue scale for pain (0-10) was collected before, and ten minutes after, treatment. A minimum visual analog pain score of 4 was required for study enrollment. Users, unaided, self-trained in the use of the device and self-administered the treatment.

Study Status: Completed June 2018

ClinicalTrials.Gov Identifier: NCT03466879

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