RecruitingNCT06519435

Non-invasive Venous Air Plethysmography Assessment of Venous Hemodynamics in Patients Suspected Deep Venous Obstruction Used in Conjunction With Intermittent Pneumatic Compression.


Sponsor

Mayo Clinic

Enrollment

500 participants

Start Date

Nov 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this research is to measure changes in venous blood flow with an air-filled bladder under an intermittent pneumatic compression device cuff (used to prevent deep venous thrombosis) or venous diagnostic device cuff (used to detect deep venous thrombosis). The devices being used in the study are investigational and not FDA-cleared.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Venous ultrasound study to evaluate for lower extremity DVT unilateral and/or bilateral within previous 72 hours.

Exclusion Criteria3

  • Patients with inaccessible target limb (ultrasound limb) due to bandages (wound, burn, lesion, etc) or cast.
  • Patients with leg trauma, fracture, above or below knee amputation, or other condition in which compressing on the calf is medically inappropriate or not possible.
  • Patients unable to provide informed written consent.

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Interventions

DEVICEMayo Dopplex ABIlity

Device used to measure lower extremity venous hemodynamic pressure

DEVICEIntermittent Pneumatic Compression (IPC)

Device used to measure lower extremity venous hemodynamic pressure


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT06519435


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