Trial Outcomes & Findings for Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection (NCT NCT06652568)
NCT ID: NCT06652568
Last Updated: 2026-03-25
Results Overview
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/clinical-and-practice-management/policy-statements/information-papers/emergency-ultrasound-standard-reporting-guidelines---2018.pdf.
COMPLETED
NA
634 participants
Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).
2026-03-25
Participant Flow
Participant milestones
| Measure |
Single Arm
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
|
|---|---|
|
Overall Study
STARTED
|
634
|
|
Overall Study
COMPLETED
|
594
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Single Arm
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
|
|---|---|
|
Overall Study
Exclusions
|
40
|
Baseline Characteristics
Determining the Validity of ThinkSono Guidance for Ultrasound Image Acquisition and Remote Detection
Baseline characteristics by cohort
| Measure |
Single Arm
n=594 Participants
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
|
|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 15 • n=138 Participants
|
|
Sex: Female, Male
Female
|
238 Participants
n=138 Participants
|
|
Sex: Female, Male
Male
|
356 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
Black
|
112 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
71 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
White
|
360 Participants
n=138 Participants
|
|
Race/Ethnicity, Customized
Other
|
51 Participants
n=138 Participants
|
|
Body Mass Index
|
29 kg/m^2
STANDARD_DEVIATION 7 • n=138 Participants
|
PRIMARY outcome
Timeframe: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).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/clinical-and-practice-management/policy-statements/information-papers/emergency-ultrasound-standard-reporting-guidelines---2018.pdf.
Outcome measures
| Measure |
Single Arm
n=594 Participants
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
|
|---|---|
|
Image Quality Adequacy
|
86.83 Percentage of scans
Interval 84.08 to 89.34
|
PRIMARY outcome
Timeframe: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).The sensitivity for overall triage performance for proximal DVT is at least 85%.
Outcome measures
| Measure |
Single Arm
n=594 Participants
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
|
|---|---|
|
Triage Sensitivity
|
92.86 Percentage of scans
Interval 86.3 to 98.4
|
PRIMARY outcome
Timeframe: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).The specificity for overall triage performance for proximal DVT is at least 30%.
Outcome measures
| Measure |
Single Arm
n=594 Participants
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
|
|---|---|
|
Triage Specificity
|
39.12 Percentage of scans
Interval 35.18 to 43.09
|
PRIMARY outcome
Timeframe: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).Prioritization specificity quantifies how reliably the system identifies patients who merit high-urgency imaging specialist assessment based on their ThinkSono scans. A high prioritization specificity means that there are very few false-positive scans that lead to patients being prioritized unnecessarily. Further details are available in the trial protocol and statistical analysis plan. ThinkSono Guidance achieves specificity for prioritizing patients of at least 93%. This means that at least 93% of scans without proximal lower extremity DVT were not labeled as false positives by reviewers of ThinkSono Guidance scans.
Outcome measures
| Measure |
Single Arm
n=594 Participants
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
|
|---|---|
|
Prioritization Specificity
|
97.96 Percentage of scans
Interval 96.77 to 99.03
|
SECONDARY outcome
Timeframe: Measured during ThinkSono Guidance scanning (median scan time of 5.4 minutes).To observe the negative-predictive-value and positive-predictive-value of ThinkSono Guidance triage performance.
Outcome measures
| Measure |
Single Arm
n=594 Participants
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
|
|---|---|
|
Predictive Values
Triage NPV
|
98.07 Percentage of scans
Interval 96.17 to 99.58
|
|
Predictive Values
Triage PPV
|
14.1 Percentage of scans
Interval 10.84 to 17.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at the time of ThinkSono Guidance scanning, during scan review by qualified clinicians, and during simulation of serial ultrasound scanning.Clinical practice guidelines for proximal compression ultrasound recommend a repeat scan within a week if the initial scan is negative, in order to identify any progression of initially undetectable thrombi. Repeat scans were unfeasible and not clinically indicated for subjects in this study, and this outcome measure was simulated. Further details are available in the trial protocol and statistical analysis plan. This figure represents the estimated sensitivity of a repeated ThinkSono Guidance scan for lower extremity proximal DVT 1 week after the initial scan, as per clinical guidelines.
Outcome measures
| Measure |
Single Arm
n=594 Participants
This arm of patients will undergo an ultrasound scan using the ThinkSono system and a comparison standard of care duplex ultrasound scan.
|
|---|---|
|
Serial Ultrasound Sensitivity
|
97.42 Percentage of scans
Interval 94.44 to 99.48
|
Adverse Events
Single Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place