CClinicalTrials.gg
RecruitingNCT06519435Updated Oct 28, 2025

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

An observational study in Deep Vein Thrombosis, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-28.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Deep Vein Thrombosis

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03

In context

Venous Thrombosis

774 studies on the registry are indexed under Venous Thrombosis; 124 are open to participants now.

This study's planned enrollment of 500 is above the median of 288 across 283 observational studies indexed under Venous Thrombosis.

Browse Venous Thrombosis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    • David Liedl · Contact · liedl.david@mayo.edu · 800-664-4542
    • Gonda Vascular Center · Contact · 507-266-6717
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06519435
Lead sponsor
Mayo Clinic
Responsible party
Damon E. Houghton (Physician, Vascular Medicine, Mayo Clinic) — Principal investigator
First posted
Jul 25, 2024
Start date
Nov 15, 2024
Primary completion
Dec 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 28, 2025

Study contacts

David Liedl
Contact
liedl.david@mayo.edu
507-266-6717
Damon Houghton, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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