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Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection
Sponsor: ThinkSono, Ltd.
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
634
Start Date
2023-11-08
Completion Date
2025-12-08
Last Updated
2026-07-17
Healthy Volunteers
No
Interventions
ThinkSono System
The ThinkSono Guidance System is a guidance software expected to help non-radiology specialist healthcare professionals produce compression ultrasound image data that meet or exceed the minimal image quality criteria for a remote diagnosis by an expert (e.g. radiologist).
Locations (5)
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