ClearUP Longitudinal Pilot Study
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ClinicalTrials.gov Identifier: NCT03888274 |
Recruitment Status :
Completed
First Posted : March 25, 2019
Results First Posted : April 2, 2020
Last Update Posted : April 2, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sinus Pain Congestion | Device: ClearUP Sinus Pain Relief | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ClearUP Longitudinal Pilot Study |
Actual Study Start Date : | November 29, 2018 |
Actual Primary Completion Date : | February 13, 2019 |
Actual Study Completion Date : | March 1, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Active |
Device: ClearUP Sinus Pain Relief
Microcurrent Device Treatment |
- Numeric Rating Scale for Pain [ Time Frame: 4 weeks ]Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.
- Congestion Quantifier 7 [ Time Frame: 4 Weeks ]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).
- Numeric Rating Scale for Pain [ Time Frame: 6 hours ]Acute Change in Numeric Rating Scale for Pain from Baseline to 6 Hours. Scale range 0, no pain, to 10 severe pain.

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Ages Eligible for Study: | 18 Years to 71 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888274
United States, California | |
Allergy and Asthma Associates of Santa Clara Valley Research Center | |
San Jose, California, United States, 95117 |
Documents provided by Tivic Health Systems:
Responsible Party: | Tivic Health Systems |
ClinicalTrials.gov Identifier: | NCT03888274 |
Other Study ID Numbers: |
CP00003 |
First Posted: | March 25, 2019 Key Record Dates |
Results First Posted: | April 2, 2020 |
Last Update Posted: | April 2, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |