N/A
N=634
Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection
Deep Vein Thrombosis · Deep Vein Thrombosis, Pulmonary Embolus
Bottom Line
View on ClinicalTrials.gov: NCT06652568 ↗Enrolled (actual)
634
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Image Quality Adequacy — 86.83 Percentage of scans
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ThinkSono System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ThinkSono, Ltd.
- Primary completion
- Dec 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Image Quality Adequacy |
86.83 | — |
| PRIMARY Triage Sensitivity |
92.86 | — |
| PRIMARY Triage Specificity |
39.12 | — |
| PRIMARY Prioritization Specificity |
97.96 | — |
| SECONDARY Predictive Values |
98.07; 14.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06652568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.