ClearUP Longitudinal Pilot Study
1 other identifier
interventional
30
1 country
1
Brief Summary
Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedResults Posted
Study results publicly available
April 2, 2020
CompletedApril 2, 2020
March 1, 2020
3 months
March 21, 2019
March 9, 2020
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Congestion Quantifier 7
4 Weeks
Numeric Rating Scale for Pain
6 hours
Study Arms (1)
Active
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117, United States
Related Publications (1)
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.
PMID: 32232107DERIVED
Results Point of Contact
- Title
- Blake Gurfein
- Organization
- Tivic Health Systems
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 25, 2019
Study Start
November 29, 2018
Primary Completion
February 13, 2019
Study Completion
March 1, 2019
Last Updated
April 2, 2020
Results First Posted
April 2, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share