Recruiting NCT06519435
Non-invasive Venous Air Plethysmography Assessment of Venous Hemodynamics in Patients Suspected Deep Venous Obstruction Used in Conjunction With Intermittent Pneumatic Compression.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mayo Dopplex ABIlity, Intermittent Pneumatic Compression (IPC).
- Who it may be relevant to
- Registry conditions: Deep Vein Thrombosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Mayo Dopplex ABIlity
Device used to measure lower extremity venous hemodynamic pressure - Device Intermittent Pneumatic Compression (IPC)
Device used to measure lower extremity venous hemodynamic pressure
Primary outcome measures
- Mayo Dopplex ABllity device Venous hemodynamic pressure [Time frame: Baseline]
- Intermittent Pneumatic Compression device Venous hemodynamic pressure [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT06519435 · 23-012242