Using ThinkSono Guidance for Ultrasound to Detect Blood Clots
Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Diagnosis
This study is testing a new mobile app that helps doctors quickly use ultrasound to find blood clots in patients with deep vein thrombosis or pulmonary embolism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ThinkSono, Ltd. Industry-sponsored |
| Drugs / interventions | cart |
| Locations | 5 sites (New York, New York and 4 other locations) |
| Trial ID | NCT06652568 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the ThinkSono Guidance System, a mobile software application that assists healthcare professionals in performing ultrasound examinations to detect deep vein thrombosis (DVT) and pulmonary embolism. By enabling non-radiologist healthcare providers to conduct ultrasound scans at the point of care, the study seeks to improve the accessibility and efficiency of DVT diagnosis. The study is a multi-site, non-randomized, double-blinded, prospective cohort investigation, focusing on the safety and efficacy of this innovative approach. The ThinkSono system has already received CE Mark approval in Europe and is currently in clinical use there.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who exhibit symptoms suggestive of deep vein thrombosis and require an ultrasound for diagnosis.
Not a fit: Patients who do not consent to participate or those who cannot undergo a conclusive imaging diagnosis due to logistical issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the speed and accuracy of DVT diagnosis, potentially reducing morbidity and healthcare costs.
How similar studies have performed: Other studies have shown promise in using handheld ultrasound devices for point-of-care diagnostics, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The participant is willing to provide written informed consent to participate in this research. * The participant is over the age of 18 * The participant has symptoms suggestive of a deep venous thrombosis (DVT) * The diagnostic DVT algorithm indicates that an ultrasound is needed Exclusion Criteria: * Patient consent not given or retracted during the study. * Local imaging specialists fail to scan the patient or fail to produce a conclusive imaging diagnosis. * Incomplete ThinkSono Guidance scan due to logistical or other issues such as pain, lack of patient cooperation, barriers such as a cast or other physical limitations.
Where this trial is running
New York, New York and 4 other locations
- NYU Langone Health — New York, New York, United States (Completed)
- Temple Health — Philadelphia, Pennsylvania, United States (Recruiting)
- Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Recruiting)
- South Texas Veterans Health System — San Antonio, Texas, United States (Recruiting)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Glenn Jacobowitz, MD — Northwell Health
- Study coordinator: Giancarlo Speranza, MD, MBA
- Email: giancarlo@thinksono.com
- Phone: 2122637311
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.