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

NCT06652568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 634

Last updated 2026-03-25

Study results available
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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.

Conditions

  • Deep Vein Thrombosis
  • Deep Vein Thrombosis, Pulmonary Embolus

Interventions

DEVICE

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).

Sponsors & Collaborators

  • NYU Langone Health

    collaborator OTHER

  • Temple Health

    collaborator UNKNOWN

  • Allegheny Health Network

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • South Texas Veterans Health Care System

    collaborator FED

  • ThinkSono, Ltd.

    lead INDUSTRY

Principal Investigators

  • Glenn Jacobowitz, MD · Northwell Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2025-12-08
Completion
2025-12-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06652568 on ClinicalTrials.gov