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

NCT06652568 | Completed Results FDA Device

• 1 other identifier: 012023
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Deep vein thrombosis; Artificial intelligence; Machine learning; Ultrasound

Outcome Measures

Primary Outcomes (4)

• Image Quality Adequacy

  ThinkSono Guidance achieves adequate image quality with an American College of Emergency Physicians (ACEP) score equal to or greater than 3 in at least 60% of scans to show that non-ultrasound-trained operators can acquire relevant cine-loops (an expectation ≥75%, lower CI ≥60%). The ACEP score is a score on a scale of 1-5 assessing utilized as the national standard for image quality evaluation. Further information is available at: https://www.acep.org/siteassets/uploads/uploaded-files/acep/clinical-and-practice-management/policy-statements/information-papers/emergency-ultrasound-standard-reporting-guidelines---2018.pdf.

  Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).

• Triage Sensitivity

  The sensitivity for overall triage performance for proximal DVT is at least 85%.

  Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).

• Triage Specificity

  The specificity for overall triage performance for proximal DVT is at least 30%.

  Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).

• Prioritization Specificity

  Prioritization specificity quantifies how reliably the system identifies patients who merit high-urgency imaging specialist assessment based on their ThinkSono scans. A high prioritization specificity means that there are very few false-positive scans that lead to patients being prioritized unnecessarily. Further details are available in the trial protocol and statistical analysis plan. ThinkSono Guidance achieves specificity for prioritizing patients of at least 93%. This means that at least 93% of scans without proximal lower extremity DVT were not labeled as false positives by reviewers of ThinkSono Guidance scans.

  Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).

Secondary Outcomes (1)

• Predictive Values

  Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).

Other Outcomes (1)

• Serial Ultrasound Sensitivity

  Measured at the time of ThinkSono Guidance scanning, during scan review by qualified clinicians, and during simulation of serial ultrasound scanning.

Study Arms (1)

Single Arm

OTHER

This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.

Device: ThinkSono System

Interventions

ThinkSono System DEVICE

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).

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Pregnant women
• Patients who undergo a local imaging scan and initiation of new treatment for DVT (e.g. lytic agents, therapeutic anticoagulation, or intervention after the local imaging scan) before a ThinkSono scan can be performed.

Sponsors & Collaborators

• NYU Langone Health: collaborator
• Temple Health: collaborator
• Allegheny Health Network: collaborator
• University of Wisconsin, Madison: collaborator
• South Texas Veterans Health Care System: collaborator
• ThinkSono, Ltd.: lead

Study Sites (5)

NYU Langone Health

New York, New York, 10016, United States

Location

Temple Health

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

South Texas Veterans Health System

San Antonio, Texas, 78229, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (8)

• Nothnagel K, Aslam MF. Evaluating the benefits of machine learning for diagnosing deep vein thrombosis compared with gold standard ultrasound: a feasibility study. BJGP Open. 2025 Jan 2;8(4):BJGPO.2024.0057. doi: 10.3399/BJGPO.2024.0057. Print 2024 Dec.

  PMID: 38866404 BACKGROUND

• Poulikidis KP, Gasparis AP, Labropoulos N. Prospective analysis of incidence, extent and chronicity of lower extremity venous thrombosis. Phlebology. 2014 Feb;29(1):37-42. doi: 10.1258/phleb.2012.012086. Epub 2013 May 6.

  PMID: 23131597 BACKGROUND

• Grosse SD, Nelson RE, Nyarko KA, Richardson LC, Raskob GE. The economic burden of incident venous thromboembolism in the United States: A review of estimated attributable healthcare costs. Thromb Res. 2016 Jan;137:3-10. doi: 10.1016/j.thromres.2015.11.033. Epub 2015 Nov 24.

  PMID: 26654719 BACKGROUND

• Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol. 2009 May;145(3):286-95. doi: 10.1111/j.1365-2141.2009.07601.x. Epub 2009 Feb 13.

  PMID: 19222476 BACKGROUND

• Roberts LN, Patel RK, Donaldson N, Bonner L, Arya R. Post-thrombotic syndrome is an independent determinant of health-related quality of life following both first proximal and distal deep vein thrombosis. Haematologica. 2014 Mar;99(3):e41-3. doi: 10.3324/haematol.2013.089870. Epub 2014 Jan 17. No abstract available.

  PMID: 24441147 BACKGROUND

• Kearon C, Julian JA, Newman TE, Ginsberg JS. Noninvasive diagnosis of deep venous thrombosis. McMaster Diagnostic Imaging Practice Guidelines Initiative. Ann Intern Med. 1998 Apr 15;128(8):663-77. doi: 10.7326/0003-4819-128-8-199804150-00011.

  PMID: 9537941 BACKGROUND

• Kainz B, Heinrich MP, Makropoulos A, Oppenheimer J, Mandegaran R, Sankar S, Deane C, Mischkewitz S, Al-Noor F, Rawdin AC, Ruttloff A, Stevenson MD, Klein-Weigel P, Curry N. Non-invasive diagnosis of deep vein thrombosis from ultrasound imaging with machine learning. NPJ Digit Med. 2021 Sep 15;4(1):137. doi: 10.1038/s41746-021-00503-7.

  PMID: 34526639 BACKGROUND

• Oppenheimer J, Mandegaran R, Staabs F, Adler A, Singohl S, Kainz B, Heinrich M, Geroulakos G, Spiliopoulos S, Avgerinos E. Remote Expert DVT Triaging of Novice-User Compression Sonography with AI-Guidance. Ann Vasc Surg. 2024 Feb;99:272-279. doi: 10.1016/j.avsg.2023.08.022. Epub 2023 Oct 10.

  PMID: 37820986 BACKGROUND

Related Links

• Study sponsor website

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Results Point of Contact

• Title: Giancarlo Speranza MD, MBA
• Organization: ThinkSono, Ltd.

giancarlo@thinksono.com

2127637111

Study Officials

• Glenn Jacobowitz, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Though not masked, the study is double blinded. Double blinding will be ensured by the ThinkSono software, as it will not be giving any indication of diagnosis or image quality to the operator. The comparison scan will be done by a qualified imaging specialist as per the standard of care at the local institution, but they will also not know the results of the ThinkSono scan. There will also be "remote qualified clinicians" reviewing the ThinkSono data (separately from local staff) who also will not know the results of the local imaging specialist. Only at the final data assessment upon study completion will outcome assessors be aware of ThinkSono device results and local site imaging results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm comparison study between the ThinkSono device and standard of care venous duplex ultrasound.

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 22, 2024
• Study Start: November 8, 2023
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)