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

NCT ID: NCT03328624

Last Updated: 2019-09-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-23

Study Completion Date

2018-04-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Deep Vein Thrombosis Venous Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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DVT Cuff users

Current or previous DVT cuff users

Group Type EXPERIMENTAL

Deep Vein Thrombosis (DVT) Cuff

Intervention Type DEVICE

Recovery Force's DVT II Cuff

Interventions

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Deep Vein Thrombosis (DVT) Cuff

Recovery Force's DVT II Cuff

Intervention Type DEVICE

Other Intervention Names

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RF1400

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Recovery Force LLC

INDUSTRY

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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David Armstrong

Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David G Armstrong, DPM, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Surgery and Director, SALSA@USC

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HS-17-00865

Identifier Type: -

Identifier Source: org_study_id

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