CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
RF Health MACdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04995601
NCT04995601N/ACompleted

Wearable Technology to Reduce Risk of DVT and Increase Patient Compliance

Recovery Force LLC·interventional·Posted Aug 9, 2021·Updated Sep 5, 2024

In Brief

A clinical study evaluating RF Health MAC for Orthopedic Disorder. Completed, enrolled 106 participants across 1 site.

Detailed Summary

The primary purpose of this study is to conduct a multi-site clinical trial of the Recovery Force Movement and Compressions (RF MAC) System. The study is a randomized comparative study of DVT prophylaxis using either standard IPC (Group 1) or the RF MAC system (Group 2) in 300 patients after TJR surgery at two study sites: Tufts Medical Center (Boston, Massachusetts) and Eskenazi Hospital (Indianapolis, Indiana). This study is funded by a Phase II SBIR awarded to Recovery Force from the National Institutes of Health, National Heart, Lung and Blood Institute (R44-HL132624-02).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 9, 2021
Enrollment StartApr 1, 2022
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 4.9 years ago

Interventions

RF Health MACdevice

The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation.