Assessing blood flow changes in patients with suspected deep vein obstruction using a non-invasive method
Non-invasive Venous Air Plethysmography Assessment of Venous Hemodynamics in Patients Suspected Deep Venous Obstruction Used in Conjunction With Intermittent Pneumatic Compression.
This study is testing a new non-invasive device to see if it can help understand blood flow changes in patients who might have deep vein thrombosis (DVT).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06519435 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate venous blood flow changes in patients suspected of having deep vein thrombosis (DVT) using a non-invasive air-filled bladder under an intermittent pneumatic compression device. The study will involve patients who have undergone a venous ultrasound within the last 72 hours to assess for DVT. The devices used in this study are investigational and not yet cleared by the FDA, focusing on improving diagnostic methods for DVT. The goal is to enhance understanding of venous hemodynamics in patients at risk for DVT.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have had a venous ultrasound indicating potential DVT within the last 72 hours.
Not a fit: Patients with conditions that prevent access to the target limb or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic techniques for detecting deep vein thrombosis, potentially reducing complications associated with the condition.
How similar studies have performed: While this approach is investigational, similar non-invasive methods have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Damon Houghton, MD — Mayo Clinic
- Study coordinator: David Liedl
- Email: liedl.david@mayo.edu
- Phone: 507-266-6717
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.