Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652568
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Diagnosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Diagnosis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DVT GUARD
Brief 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 andor 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
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 1000 people over to 300000 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 sonographersradiologists are based most often ie 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 eg nurses non-radiologist physicians general practitioners and other allied healthcare professionals to carry out the compression ultrasound exam with minimal training
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 eg 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 the ThinkSono Guidance System as per the intended use defined as
ThinkSono Guidance System 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
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 sonographersradiologists are based most often ie 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 eg nurses non-radiologist physicians general practitioners and other allied healthcare professionals to carry out the compression ultrasound exam with minimal training
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 eg 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 the ThinkSono Guidance System as per the intended use defined as
ThinkSono Guidance System 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None