ClearUP Longitudinal Pilot Study

Tivic Health Systems

Status: Completed

Conditions: Sinus Pain; Congestion

Treatments: Device: ClearUP Sinus Pain Relief

Study type: Interventional

Funder types: Industry

Identifiers

NCT03888274

CP00003

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 71 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Active

Experimental group

Treatment:

Device: ClearUP Sinus Pain Relief