Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection
Key facts
- Who runs it
- ThinkSono, Ltd.
- Where
- Madison, New York, Philadelphia, Pittsburgh, and San Antonio, United StatesSee the 5 sites
- Trial code
- Status
- Completed
- People taking part
- 634 people enrolled
- Started
- 8 Nov 2023
- Ended
- 8 Dec 2025
- Type of study
- Interventional
- Treatments tested
- ThinkSono System
- Record updated
- 17 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in United States
- University of Wisconsin - MadisonMadison, United States
- NYU Langone HealthNew York, United States
- Temple HealthPhiladelphia, United States
- Allegheny Health NetworkPittsburgh, United States
- South Texas Veterans Health SystemSan Antonio, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Single ArmOther group
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
Treatment: ThinkSono System
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 17 July 2026