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NCT06652568 · ClinicalTrials.gov registry record · NA
Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection
A NA study of Deep Vein Thrombosis and Deep Vein Thrombosis, Pulmonary Embolus, sponsored by ThinkSono.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 5
- Study locations
NCT06652568: Recruiting NA study of Deep Vein Thrombosis and Deep Vein Thrombosis, Pulmonary Embolus, sponsored by ThinkSono.
NCT06652568 is a NA study of Deep Vein Thrombosis and Deep Vein Thrombosis, Pulmonary Embolus that is actively recruiting participants, run by ThinkSono. The registered enrollment target is 500 participants, below the 7,911-participant average among 24 other Deep Vein Thrombosis trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06652568, a NA study of Deep Vein Thrombosis and Deep Vein Thrombosis, Pulmonary Embolus, is actively recruiting participants, sponsored by ThinkSono.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
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/clin
Conditions Studied
Interventions
- DEVICE ThinkSono System
Study Locations (5)
Pennsylvania
- Temple Health - Philadelphia
- Allegheny Health Network - Pittsburgh
New York
- NYU Langone Health - New York
Texas
- South Texas Veterans Health System - San Antonio
Wisconsin
- University of Wisconsin-Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-11-08 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What NCT06652568 shows while recruiting
NCT06652568 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 7,911-participant average among 24 other Deep Vein Thrombosis trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Deep Vein Thrombosis appearing as the primary indexed condition, and to 1 intervention - of which ThinkSono System is the first listed.
NCT06652568 lists 5 locations in 4 states (Pennsylvania, New York, Texas).
Frequently Asked Questions
What is clinical trial NCT06652568 about?
NCT06652568 is a clinical study titled "Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection". 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 ...
What is the current status of trial NCT06652568?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2023-11-08. Estimated completion is 2025-12-31.
What conditions does trial NCT06652568 study?
This clinical trial studies the following conditions: Deep Vein Thrombosis, Deep Vein Thrombosis, Pulmonary Embolus.
What interventions are being tested in trial NCT06652568?
The interventions under investigation include: ThinkSono System (DEVICE).
Who is sponsoring clinical trial NCT06652568?
This trial is sponsored by ThinkSono, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06652568 being conducted?
This trial has 5 study locations across New York, Pennsylvania, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06652568's enrollment target sits among peer trials
500 7th of 24 higher than 17 of 24 other Deep Vein Thrombosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Deep Vein Thrombosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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