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

NCT06519435 | Recruiting FDA Device

• 1 other identifier: 23-012242
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (2)

• Mayo Dopplex ABllity device Venous hemodynamic pressure

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

  Baseline

• Intermittent Pneumatic Compression device Venous hemodynamic pressure

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

  Baseline

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with venous ultrasound evaluation performed to rule out deep vein thrombosis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Damon Houghton, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Liedl

CONTACT

507-266-6717; liedl.david@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Vascular Medicine

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)