A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff
- Conditions
- Deep Vein ThrombosisVenous Thrombosis
- Registration Number
- NCT03328624
- Lead Sponsor
- University of Southern California
- Brief Summary
A preliminary clinical usability study to assess design, comfort, wearability, and acceptance of Recovery Force's Deep vein thrombosis (DVT) cuff
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Male or Female Age 18-65 who have had exposure with a DVT cuff on the calf within the last 6 months from a previous or current clinical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Comfort and Patient Acceptance 1 day 1. FULL SCALE NAME: Wearability, comfort, and acceptance of the DVT cuff Scale. Created a likert-type scale in RedCAP with values from 0 to 10, with higher score equaling better outcome.
2. TIME FRAME: Each participant wore the DVT cuff under study for 20 minutes, and evaluated their experience using the scale above.
Evaluated through User Questionnaire: Recovery Force DVT Cuff - Post-Demonstration Patient Questionnaire; and subject interview
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Southern California
🇺🇸Los Angeles, California, United States
University of Southern California🇺🇸Los Angeles, California, United States