Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection (NCT06652568) | Clinical Trial Compass
CompletedNot Applicable
Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection
United States634 participantsStarted 2023-11-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Image Quality Adequacy
Timeframe: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).
2
Triage Sensitivity
Timeframe: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).
3
Triage Specificity
Timeframe: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).
4
Prioritization Specificity
Timeframe: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).