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

Description

The purpose of this study is to confirm the safety and efficacy of the ThinkSono Guidance System, 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 diagnose 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. The ThinkSono Guidance System 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.

Conditions

Deep Vein Thrombosis, Deep Vein Thrombosis, Pulmonary Embolus

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Study Overview

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Study Details

Study overview

The purpose of this study is to confirm the safety and efficacy of the ThinkSono Guidance System, 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 diagnose 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. The ThinkSono Guidance System 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.

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

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

Condition
Deep Vein Thrombosis
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10016

Philadelphia

Temple Health, Philadelphia, Pennsylvania, United States, 19140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

ThinkSono, Ltd.,

Glenn Jacobowitz, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2025-04-01