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| Name | Class |
|---|---|
| Recovery Force LLC | INDUSTRY |
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A preliminary clinical usability study to assess design, comfort, wearability, and acceptance of Recovery Force's Deep vein thrombosis (DVT) cuff
A single site, observational study will be conducted at the University of Southern California (USC) with participants who have and/or have had previous experience with DVT pneumatic cuffs. Study staff will examine participants overall experience, product functionality and perceived adherence to Recovery Force's DVT II cuff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DVT Cuff users | Experimental | Current or previous DVT cuff users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Vein Thrombosis (DVT) Cuff | Device | Recovery Force's DVT II Cuff |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort and Patient Acceptance |
Evaluated through User Questionnaire: Recovery Force DVT Cuff - Post-Demonstration Patient Questionnaire; and subject interview | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| David G Armstrong, DPM, MD, PhD | Professor of Surgery and Director, SALSA@USC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DVT Cuff Users | Current or previous DVT cuff users Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DVT Cuff Users | Current or previous DVT cuff users Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Comfort and Patient Acceptance |
Evaluated through User Questionnaire: Recovery Force DVT Cuff - Post-Demonstration Patient Questionnaire; and subject interview | Posted | Mean | Standard Deviation | score on a scale | 1 day |
|
|
1 day
Single-use study of DVT cuff
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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 | DVT Cuff Users | Current or previous DVT cuff users Deep Vein Thrombosis (DVT) Cuff: Recovery Force's DVT II Cuff |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | SALSA@USC | 323-442-5528 | dhuyvett@usc.edu |
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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 11, 2017 | Sep 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Participants |
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| 0 |
| 36 |
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| 36 |
| 0 |
| 36 |
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