ClearUP Longitudinal Pilot Study

Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.

Study Overview

• Status: Completed
• Conditions: Congestion; Sinus Pain
• Intervention / Treatment: Device: ClearUP Sinus Pain Relief

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95117
      • Allergy and Asthma Associates of Santa Clara Valley Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-71 years of age (inclusive)
• Present with symptoms of sinus pain or facial pain in the forehead, periorbital, facial, or nasal region
• Current pain score ≥ 5 (Numeric Rating Scale 0-10)
• Frequency of sinus/facial pain at least twice weekly for 1 month
• Able to read and understand English
• Agree to participate in the study
• Able and willing to provide Informed Consent

Exclusion Criteria:

• Do not meet Inclusion Criteria
• Currently taking or recently taken any oral steroid medications in the last 90 days
• Sinus surgery in previous 90 days
• History of Chronic Migraine (≥ 15 headache days per month)
• Pain location in the vertex, occiput, or temporal region of the skull or in mandibular region
• Purulent rhinorrhea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active	Device: ClearUP Sinus Pain Relief; Microcurrent Device Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale for Pain	Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Congestion Quantifier 7	Change in Congestion Quantifier 7 from Baseline to Four Weeks. Congestion Quantifier 7 is a 7 item questionnaire that quantifies congestion symptom severity. It is scored from 0 (no congestion symptoms) to 28 (severe congestions symptoms).	4 Weeks
Numeric Rating Scale for Pain	Acute Change in Numeric Rating Scale for Pain from Baseline to 6 Hours. Scale range 0, no pain, to 10 severe pain.	6 hours

Collaborators and Investigators

• Sponsor: Tivic Health Systems

Publications and helpful links

General Publications

• Goldsobel AB, Prabhakar N, Gurfein BT. Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion. Bioelectron Med. 2019 Nov 20;5:18. doi: 10.1186/s42234-019-0035-x. eCollection 2019. Erratum In: Bioelectron Med. 2020 Jan 30;6:2.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CP00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No