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NCT Number: NCT06519435

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

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.

Recruiting

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Mayo Dopplex ABIlity

Device

Device used to measure lower extremity venous hemodynamic pressure

Intermittent pneumatic compression (IPC)

Device

Device used to measure lower extremity venous hemodynamic pressure

Primary outcomes

  1. Mayo Dopplex ABllity device Venous hemodynamic pressure

    Time frame: Baseline

    Venous hemodynamic pressure to be measured from both the recumbent and sitting positions using the Mayo Dopplex ABllity device. Measured as mmHg.

  2. Intermittent Pneumatic Compression device Venous hemodynamic pressure

    Time frame: Baseline

    Venous hemodynamic pressure to be measured from both the recumbent and sitting positions using the IPC device. Measured as mmHg.

Study contacts

Contact information is provided by the study sponsor or research team.

David Liedl

CONTACT

[email protected]

507-266-6717

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 25, 2024
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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