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Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

NCT04232501 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-01-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of a new leg compression device in preventing post-surgical deep vein thrombosis (blood clot) that can occur after major and complex spine surgery. The investigators aim to show that this new compression device is no worse than the standard sequential compression device (SCD) at preventing DVT and may be able to detect deep vein thrombosis in patients who are not typically screened for this diagnosis after surgery. This new device may be able to capture an important post-surgical complication while providing a more comfortable treatment option.

Conditions

  • Deep Venous Thrombosis

Interventions

DEVICE

Cirvo Compression device

Patients will wear Cirvo compression device during the surgery, after surgery and will be discharged to home with the device to wear at home as the per study protocol instructions.

Sponsors & Collaborators

Principal Investigators

  • Adam Schlifke · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2021-01-08
Completion
2021-01-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04232501 on ClinicalTrials.gov