RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-08
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06652568

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The participant is willing to provide written informed consent to participate in this research.
  2. * The participant is over the age of 18
  3. * The participant has symptoms suggestive of a deep venous thrombosis (DVT)
  4. * The diagnostic DVT algorithm indicates that an ultrasound is needed
  1. * Patient consent not given or retracted during the study.
  2. * Local imaging specialists fail to scan the patient or fail to produce a conclusive imaging diagnosis.
  3. * 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.

Contacts and Locations

Study Contact

Giancarlo Speranza, MD, MBA
CONTACT
2122637311
giancarlo@thinksono.com
Fouad Al Noor
CONTACT
fouad@thinksono.com

Principal Investigator

Glenn Jacobowitz, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States
Temple Health
Philadelphia, Pennsylvania, 19140
United States

Collaborators and Investigators

Sponsor: ThinkSono, Ltd.

  • Glenn Jacobowitz, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2023-11-08
Study Completion Date2025-04-01

Terms related to this study

Keywords Provided by Researchers

  • Deep vein thrombosis
  • Artificial intelligence
  • Machine learning
  • Ultrasound

Additional Relevant MeSH Terms

  • Deep Vein Thrombosis
  • Deep Vein Thrombosis, Pulmonary Embolus