Trial Outcomes & Findings for ClearUP Longitudinal Pilot Study (NCT NCT03888274)

NCT ID: NCT03888274

Last Updated: 2020-04-02

Results Overview

Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2020-04-02

Participant Flow

Participant milestones

Measure	Active ClearUP Sinus Pain Relief: Microcurrent Device Treatment
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Active n=30 Participants ClearUP Sinus Pain Relief: Microcurrent Device Treatment
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=30 Participants
Age, Categorical >=65 years	1 Participants n=30 Participants
Age, Continuous	43.4 Years STANDARD_DEVIATION 12.1 • n=30 Participants
Sex: Female, Male Female	21 Participants n=30 Participants
Sex: Female, Male Male	9 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 4 weeks

Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.

Outcome measures

Measure	Active n=30 Participants ClearUP Sinus Pain Relief: Microcurrent Device Treatment
Numeric Rating Scale for Pain Baseline	6.5 score on a scale Standard Error 0.20
Numeric Rating Scale for Pain 4 Weeks	3.6 score on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Active n=30 Participants ClearUP Sinus Pain Relief: Microcurrent Device Treatment
Congestion Quantifier 7 Baseline	18.1 score on a scale Standard Error 0.85
Congestion Quantifier 7 4 Weeks	11.0 score on a scale Standard Error 1.05

SECONDARY outcome

Timeframe: 6 hours

Acute Change in Numeric Rating Scale for Pain from Baseline to 6 Hours. Scale range 0, no pain, to 10 severe pain.

Outcome measures

Measure	Active n=30 Participants ClearUP Sinus Pain Relief: Microcurrent Device Treatment
Numeric Rating Scale for Pain Baseline	6.5 score on a scale Standard Error 0.20
Numeric Rating Scale for Pain 6 Hours	4.3 score on a scale Standard Error 0.37

Adverse Events

Active

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active n=30 participants at risk ClearUP Sinus Pain Relief: Microcurrent Device Treatment
Skin and subcutaneous tissue disorders Skin Irritation	6.7% 2/30 • Number of events 2 • Adverse event data were collected during the 4 week duration of the study. A serious adverse event is defined as one that results in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Nervous system disorders Headache	3.3% 1/30 • Number of events 1 • Adverse event data were collected during the 4 week duration of the study. A serious adverse event is defined as one that results in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Musculoskeletal and connective tissue disorders Eyelid Twitch	3.3% 1/30 • Number of events 1 • Adverse event data were collected during the 4 week duration of the study. A serious adverse event is defined as one that results in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

Additional Information

Blake Gurfein

Tivic Health Systems

Phone: 5615737652

Email: blake.gurfein@tivichealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place