A Preliminary Clinical Usability Study to Assess Design, Comfort, Wearability, and Acceptance of Recovery Force's Deep Vein Thrombosis (DVT) Cuff
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Deep Vein Thrombosis
- Sponsor
- University of Southern California
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Comfort and Patient Acceptance
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
David Armstrong
Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA)
University of Southern California
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Comfort and Patient Acceptance
Time Frame: 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