Deep Vein ThrombosisDVT GUARDNCT06652568
Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection
A study testing ThinkSono System in people with Deep Vein Thrombosis and Deep Vein Thrombosis, Pulmonary Embolus, run by ThinkSono, Ltd. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Deep Vein Thrombosis, Pulmonary Embolus
- What is being tested?
- ThinkSono System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Nov 2023to 8 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Wisconsin-Madison
Madison, Wisconsin, 53792
NYU Langone Health
New York, New York, 10016
Temple Health
Philadelphia, Pennsylvania, 19140
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
South Texas Veterans Health System
San Antonio, Texas, 78229
About this study
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.
Read the detailed description
Deep vein thrombosis (DVT) is well recognized to cause significant morbidity and mortality both at the time of diagnosis and post-diagnosis. With an estimated incidence of 1- 2 per 1,000 people, over to 300,000 people in the US will be diagnosed with venous thromboembolism (VTE) per annum and two-thirds of these will be DVT. However, positive cases only represent 12-25% of the total number of patients who present with suspected DVT. In other words, between 75-88% of suspected DVT cases, when fully investigated, are negative. Estimates have placed the yearly cost of VTE to the US healthcare system at up to $10 billion.
It is notoriously difficult to diagnose a DVT by clinical acumen alone. The standard approach to making a diagnosis of proximal DVT currently involves an algorithm combining pre-test probability assessment through the Wells score, and compression ultrasonography. Handheld ultrasound probes have recently become available. These probes have enabled 'app-based' compression ultrasonography to be performed without the need for bulky cart or laptop-based ultrasound machines. These new machines have a small form factor, meaning only the ultrasound probe is required for diagnostic purposes in conjunction with a smartphone or tablet.
At present, although the new handheld probes are smaller and are better suited for point of care diagnosis, they still require an experienced radiologist or sonographer to perform the compression exam. This means that these devices can only be used wherever sonographers/radiologists are based most often i.e. hospital radiology departments. However, due to recent advances in "machine learning", software is now being developed for these 'app-based' probes that can assist non-radiology specialist healthcare professionals (e.g. nurses, non-radiologist physicians, general practitioners and other allied healthcare professionals) to carry out the compression ultrasound exam with minimal training.
ThinkSono Guidance 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). The ThinkSono system is CE Mark approved in the European Union and in clinical use in Europe.
This study is a multi-site non-randomized, double-blinded, prospective cohort pivotal study. The purpose of this study is to confirm the safety and efficacy of ThinkSono Guidance as per the intended use defined as:
ThinkSono Guidance is a guidance, data acquisition and communication tool that guides non-ultrasound-trained healthcare staff to collect point of care compression ultrasound data in the proximal deep venous system of the lower extremity for interpretation by qualified clinicians.
- Being tested
- ThinkSono System
- Keywords
- Deep vein thrombosis, Artificial intelligence, Machine learning, Ultrasound
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThinkSono SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ThinkSono System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).
Secondary outcomes (4)
Triage Sensitivity
The sensitivity for overall triage performance for proximal DVT is at least 85%.
Measured: 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: 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: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).
Predictive Values
To observe the negative-predictive-value and positive-predictive-value of ThinkSono Guidance triage performance.
Measured: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start8 Nov 2023
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm comparison study between the ThinkSono device and standard of care venous duplex ultrasound.
- Masking
- None (open label)
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThinkSono, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NYU Langone Health, Temple Health, Allegheny Health Network, University of Wisconsin, Madison, South Texas Veterans Health Care System
- Responsible party
- Sponsor
- Investigators
- Glenn Jacobowitz, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652568
- Sponsor's protocol ID
- 012023
- Acronym
- DVT GUARD
- Status last verified
- Feb 2026
- First submitted
- 12 Oct 2024
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38866404Poulikidis 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.
PubMed 23131597Grosse 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.
PubMed 26654719Prandoni 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.
PubMed 19222476Roberts 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.
PubMed 24441147Kearon 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.
PubMed 9537941Kainz 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.
PubMed 34526639Oppenheimer 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.
PubMed 37820986