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NCT03328624 Clinical Trial

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

Deep Vein Thrombosis Clinical Trial

Official title:
A Preliminary Clinical Usability Study to Assess Design, Comfort, Wearability, and Acceptance of Recovery Force's Deep Vein Thrombosis (DVT) Cuff

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03328624
Other study ID # HS-17-00865
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 23, 2018
Est. completion date April 25, 2018

Study information
Verified date September 2019
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A preliminary clinical usability study to assess design, comfort, wearability, and acceptance of Recovery Force's Deep vein thrombosis (DVT) cuff

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 information / eligibility
Status Completed
Enrollment 36
Est. completion date April 25, 2018
Est. primary completion date March 6, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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:

-

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Deep Vein Thrombosis (DVT) Cuff
Recovery Force's DVT II Cuff

Locations
Country Name City State
United States University of Southern California Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
University of Southern California Recovery Force LLC.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comfort and Patient Acceptance 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.
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		 1 day
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