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ClearUP Longitudinal Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03888274
Recruitment Status : Completed
First Posted : March 25, 2019
Results First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Tivic Health Systems

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

Condition or disease Intervention/treatment Phase
Sinus Pain Congestion Device: ClearUP Sinus Pain Relief Not Applicable

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Device: ClearUP Sinus Pain Relief
Microcurrent Device Treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States, 95117
Sponsors and Collaborators
Tivic Health Systems
  Study Documents (Full-Text)

Documents provided by Tivic Health Systems:
Study Protocol and Statistical Analysis Plan  [PDF] October 30, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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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