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Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearUP Sinus Pain Relief | Device | Microcurrent Device Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Numeric Rating Scale for Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy and Asthma Associates of Santa Clara Valley Research Center | San Jose | California | 95117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32232107 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | ClearUP Sinus Pain Relief: Microcurrent Device Treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | ClearUP Sinus Pain Relief: Microcurrent Device Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | score on a scale | 4 weeks |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | ClearUP Sinus Pain Relief: Microcurrent Device Treatment | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Mild skin erythema |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Blake Gurfein | Tivic Health Systems | 5615737652 | blake.gurfein@tivichealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2018 | Mar 9, 2020 | Prot_SAP_000.pdf |
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Acute Change in Numeric Rating Scale for Pain from Baseline to 6 Hours. Scale range 0, no pain, to 10 severe pain. |
| 6 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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). | Posted | Mean | Standard Error | score on a scale | 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. | Posted | Mean | Standard Error | score on a scale | 6 hours |
|
|
|
| 30 |
| 0 |
| 30 |
| 4 |
| 30 |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Eyelid Twitch | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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