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Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

Effect of Novel Sequential Compression Device on the Incidence of Deep Venous Thrombosis on Complex Surgical Spine Patients

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04232501
Enrollment
0
Registered
2020-01-18
Start date
2021-01-08
Completion date
2021-01-08
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Venous Thrombosis

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.

Interventions

DEVICECirvo 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

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for complex spine surgery at Stanford Hospital

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Deep Vein Thrombosis (DVT)Within four weeks after surgeryNumber of participants with DVT diagnosed by ultrasound after complex spine surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026