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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
New York
NYU Langone Health
COMPLETED
New York
Pennsylvania
Temple Health
RECRUITING
Philadelphia
Allegheny Health Network
RECRUITING
Pittsburgh
Texas
South Texas Veterans Health System
RECRUITING
San Antonio
Wisconsin
University of Wisconsin-Madison
RECRUITING
Madison
Contact Information
Primary
Giancarlo Speranza, MD, MBA
giancarlo@thinksono.com
2122637311
Backup
Fouad Al Noor
fouad@thinksono.com
Time Frame
Start Date: 2023-11-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 500
Treatments
Other: Comparison Arm
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
Sponsors
Collaborators: NYU Langone Health, Temple Health, South Texas Veterans Health Care System, Allegheny Health Network, University of Wisconsin, Madison
Leads: ThinkSono, Ltd.

This content was sourced from clinicaltrials.gov