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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06519435
Enrollment
500
Registered
2024-07-25
Start date
2024-11-15
Completion date
2027-04-30
Last updated
2025-10-28

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

Conditions

Deep Vein Thrombosis

Brief 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.

Interventions

DEVICEMayo Dopplex ABIlity

Device used to measure lower extremity venous hemodynamic pressure

Device used to measure lower extremity venous hemodynamic pressure

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Mayo Dopplex ABllity device Venous hemodynamic pressureBaselineVenous hemodynamic pressure to be measured from both the recumbent and sitting positions using the Mayo Dopplex ABllity device. Measured as mmHg.
Intermittent Pneumatic Compression device Venous hemodynamic pressureBaselineVenous hemodynamic pressure to be measured from both the recumbent and sitting positions using the IPC device. Measured as mmHg.

Countries

United States

Contacts

Primary ContactDavid Liedl
liedl.david@mayo.edu507-266-6717

Outcome results

None listed

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