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Completed

NCT Number: NCT03328624

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

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

Completed

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Deep Vein Thrombosis (DVT) Cuff

Device

Recovery Force's DVT II Cuff

Other names: RF1400

Primary outcomes

  1. Comfort and Patient Acceptance

    Time frame: 1 day

    • 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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Recovery Force LLC

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2017
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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