A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis; Venous Thrombosis
• Interventions: Device: Deep Vein Thrombosis (DVT) Cuff

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Study Start: 2018-01-23
• Primary Completion: 2018-03-06
• Study Completion: 2018-04-25
• Results First Submitted: 2019-04-18
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-03
• Last Update Submitted: 2019-09-03
• Results First Posted: 2019-09-06
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DVT Cuff users	Deep Vein Thrombosis (DVT) Cuff	Current or previous DVT cuff users

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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States