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Procedure

ThinkSono System for Deep Vein Thrombosis (DVT GUARD Trial)

N/A
Recruiting
Led By Glenn Jacobowitz, MD
Research Sponsored by ThinkSono, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The participant has symptoms suggestive of a deep venous thrombosis (DVT)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 8 months.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new software tool called the ThinkSono Guidance System, which helps healthcare professionals detect blood clots in veins using ultrasound. The software is already approved in Europe. Typically,

Who is the study for?
This trial is for individuals who may have blood clots in their veins, such as those with pulmonary embolism or deep vein thrombosis. It's open to patients where healthcare professionals suspect a clot and need an ultrasound diagnosis. Specific eligibility criteria are not provided, but typically include adults who consent to participate.
What is being tested?
The ThinkSono System, a mobile app designed to guide healthcare providers through conducting ultrasounds for blood clot detection at the point of care, is being tested for its safety and effectiveness compared to traditional methods.
What are the potential side effects?
Since the intervention involves using software guidance for ultrasound imaging rather than a new medication or invasive procedure, significant side effects are not anticipated. However, any discomfort or risks related to standard ultrasound procedures still apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am experiencing symptoms that may indicate a blood clot in my veins.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 8 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 8 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Image quality adequacy
Secondary study objectives
ThinkSono system sensitivity
ThinkSono system specificity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Comparison ArmExperimental Treatment1 Intervention
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.

Find a Location

Who is running the clinical trial?

ThinkSono, Ltd.Lead Sponsor
NYU Langone HealthOTHER
1,415 Previous Clinical Trials
855,703 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
Temple HealthUNKNOWN
Allegheny Health NetworkUNKNOWN
5 Previous Clinical Trials
621 Total Patients Enrolled
Glenn Jacobowitz, MDPrincipal InvestigatorNYU Langone Health
~36 spots leftby Jan 2025
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