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

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ClinicalTrials.gov Identifier: NCT03328624
Recruitment Status : Completed
First Posted : November 1, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Recovery Force LLC.
Information provided by (Responsible Party):
David Armstrong, 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

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Venous Thrombosis Device: Deep Vein Thrombosis (DVT) Cuff Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Preliminary Clinical Usability Study to Assess Design, Comfort, Wearability, and Acceptance of Recovery Force's Deep Vein Thrombosis (DVT) Cuff
Actual Study Start Date : January 23, 2018
Actual Primary Completion Date : March 6, 2018
Actual Study Completion Date : April 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Recovery Force's DVT II cuff Device: Deep Vein Thrombosis (DVT) Cuff
Recovery Force's DVT II Cuff
Other Name: RF1400




Primary Outcome Measures :
  1. Device Wearability [ Time Frame: 3 months ]
    Evaluated through USE Questionnaire (Usefulness, Satisfaction, and Ease of use)

  2. Comfort and patient acceptance [ Time Frame: 3 months ]
    Evaluated through USE Questionnaire and subject interview


Secondary Outcome Measures :
  1. Device Usability [ Time Frame: 3 months ]
    Evaluated through Questionnaire of Usability Evaluation (QUE) modified for DVT Cuffs

  2. Design-Human Factors [ Time Frame: 3 months ]
    Evaluated through Questionnaire of Usability Evaluation (QUE) modified for DVT Cuffs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328624


Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Recovery Force LLC.
Investigators
Principal Investigator: David G Armstrong, DPM, MD, PhD Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA)

Responsible Party: David Armstrong, Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA), University of Southern California
ClinicalTrials.gov Identifier: NCT03328624     History of Changes
Other Study ID Numbers: HS-17-00865
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases