NCT03328624

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1 month

First QC Date

October 9, 2017

Results QC Date

April 18, 2019

Last Update Submit

September 3, 2019

Conditions

Deep Vein ThrombosisVenous Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Comfort and Patient Acceptance

    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

    1 day

Study Arms (1)

DVT Cuff users

EXPERIMENTAL

Current or previous DVT cuff users

Device: Deep Vein Thrombosis (DVT) Cuff

Interventions

Deep Vein Thrombosis (DVT) CuffDEVICE

Recovery Force's DVT II Cuff

Also known as: RF1400
DVT Cuff users

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Research Coordinator
Organization
SALSA@USC
dhuyvett@usc.edu
323-442-5528

Study Officials

  • David G Armstrong, DPM, MD, PhD

    Professor of Surgery and Director, SALSA@USC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA)

Study Record Dates

First Submitted

October 9, 2017

First Posted

November 1, 2017

Study Start

January 23, 2018

Primary Completion

March 6, 2018

Study Completion

April 25, 2018

Last Updated

September 6, 2019

Results First Posted

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)