Back to resultsA Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff
Primary Purpose
Deep Vein Thrombosis, Venous Thrombosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Vein Thrombosis (DVT) Cuff
Sponsored by
About this trial
This is an interventional other trial for Deep Vein Thrombosis
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:
-
Sites / Locations
- University of Southern California
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DVT Cuff users
Arm Description
Current or previous DVT cuff users
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03328624
First Posted
October 9, 2017
Last Updated
September 3, 2019
Sponsor
University of Southern California
Collaborators
Recovery Force LLC
1. Study Identification
Unique Protocol Identification Number
NCT03328624
Brief Title
A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff
Official Title
A Preliminary Clinical Usability Study to Assess Design, Comfort, Wearability, and Acceptance of Recovery Force's Deep Vein Thrombosis (DVT) Cuff
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
March 6, 2018 (Actual)
Study Completion Date
April 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Recovery Force LLC
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Venous Thrombosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DVT Cuff users
Arm Type
Experimental
Arm Description
Current or previous DVT cuff users
Intervention Type
Device
Intervention Name(s)
Deep Vein Thrombosis (DVT) Cuff
Other Intervention Name(s)
RF1400
Intervention Description
Recovery Force's DVT II Cuff
Primary Outcome Measure Information:
Title
Comfort and Patient Acceptance
Description
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
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Armstrong, DPM, MD, PhD
Organizational Affiliation
Professor of Surgery and Director, SALSA@USC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff
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