Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection

Completed · Not applicable

Conditions studied: Deep Vein Thrombosis, Deep Vein Thrombosis, Pulmonary Embolus

In brief

The purpose of this study is to confirm the safety and efficacy of ThinkSono Guidance, a software data collection and communication tool designed to collect ultrasound data to help detect blood clots in veins. The ThinkSono system is CE Mark approved in the European Union and in clinical use in Europe. Usually, when an ultrasound is conducted to detect blood clots in veins, a sonographer (trained technologist who conducts ultrasounds) and/or radiologist will conduct the procedure, including a compression ultrasound exam, and the scan may require a bulky cart and ultrasound equipment. ThinkSono Guidance is a mobile software application that enables other healthcare professionals such as nurses, non-radiologist physicians including general practitioners, and other allied healthcare professionals to perform the ultrasound at the point of care using guidance from the software app. This is a multi-site non-randomized, double-blinded, prospective cohort pivotal study.

Key facts

Study ID

NCT06652568

Run by

ThinkSono, Ltd.

People needed

634

Starts

2023-11-08

Expected to finish

2025-12-08

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Pregnant women
• Patients who undergo a local imaging scan and initiation of new treatment for DVT (e.g. lytic agents, therapeutic anticoagulation, or intervention after the local imaging scan) before a ThinkSono scan can be performed.

Where it is running

• NYU Langone Health — New York, New York, United States
• Temple Health — Philadelphia, Pennsylvania, United States
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States
• South Texas Veterans Health System — San Antonio, Texas, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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