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Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

Primary Purpose

Deep Venous Thrombosis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cirvo Compression device
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep Venous Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for complex spine surgery at Stanford Hospital

Exclusion Criteria:

  • Pregnancy
  • Non-decisional capacity
  • Incarcerated persons
  • Any hereditary or acquired coagulopathy

Sites / Locations

  • Stanford Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cirvo Compression device post surgery

Standard of Care Post Surgery

Arm Description

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.

Patients receive standard-issue SCDs (pneumatic compression) and wear in surgery and after surgery until they are discharged home.

Outcomes

Primary Outcome Measures

Incidence of Deep Vein Thrombosis (DVT)
Number of participants with DVT diagnosed by ultrasound after complex spine surgery

Secondary Outcome Measures

Full Information

First Posted
January 14, 2020
Last Updated
January 8, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04232501
Brief Title
Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study
Official Title
Effect of Novel Sequential Compression Device on the Incidence of Deep Venous Thrombosis on Complex Surgical Spine Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID-19, Radial slowed their operations. Hence the investigational device is not available.
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
January 8, 2021 (Anticipated)
Study Completion Date
January 8, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Compression therapy of the leg is a proven and well-established modality to prevent deep vein thrombosis in immobilized and post-surgical patients. The investigators aim to compare a new sequential compression for the leg that utilizes a servo motor for compression as opposed to a traditional pneumatic motor that is typically used in the hospital and after surgery. Pneumatic sequential compression devices are cumbersome, expensive and not mobile. This new compression device was developed to provide a cheaper, mobile device that can be worn by the patient after surgery and while at home during ambulation. The addition of the servo motor and fine sensors may also be able to detect sub-clinical DVT's that contribute to post-surgical pulmonary embolus and post-surgical complications. The investigators aim to learn how this new device performs in the subset of patients undergoing complex spine surgery, the incidence of post-surgical DVT with this new device compared to traditional SCD and if this new device is capable of detecting sub-clinical post-surgical DVT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Venous Thrombosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cirvo Compression device post surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care Post Surgery
Arm Type
No Intervention
Arm Description
Patients receive standard-issue SCDs (pneumatic compression) and wear in surgery and after surgery until they are discharged home.
Intervention Type
Device
Intervention Name(s)
Cirvo Compression device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Deep Vein Thrombosis (DVT)
Description
Number of participants with DVT diagnosed by ultrasound after complex spine surgery
Time Frame
Within four weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for complex spine surgery at Stanford Hospital Exclusion Criteria: Pregnancy Non-decisional capacity Incarcerated persons Any hereditary or acquired coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Schlifke
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

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