ClearUP Longitudinal Pilot Study

Congestion Clinical Trial

Official title:

ClearUP Longitudinal Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888274
• Other study ID #: CP00003
• Status: Completed
• Phase: N/A
• Start date: November 29, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2020
• Source: Tivic Health Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 71 Years

Eligibility

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

Related Conditions & MeSH terms

• Congestion
• Sinus Pain

Intervention

Device:
• ClearUP Sinus Pain Relief
Microcurrent Device Treatment

Locations

Country	Name	City	State
United States	Allergy and Asthma Associates of Santa Clara Valley Research Center	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Tivic Health Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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