DVT Evaluation Using POCUS for Diagnosis and Treatment

April 7, 2026 updated by: Stephanie A. Carey, MD, Milton S. Hershey Medical Center

Improving Lower Extremity DVT Outcomes in the Outpatient Setting: An Evaluation of 3-Point of Care Ultrasound for Timely Diagnosis and Treatment

This study will include approximately 50 patients who will be enrolled if there is suspicion of lower extremity deep vein thrombosis (DVT). Each patient will receive a point-of-care ultrasound performed by physicians in an outpatient clinic. All patients will receive a subsequent confirmatory gold standard venous duplex ultrasonography. The investigators will compare time to diagnosis and treatment initiation and evaluate short-term clinical outcomes, including pulmonary embolism, hospitalization, ICU care, and mortality.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health, Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Penn State health patient
  • 18 years and older
  • English speaking
  • Presentation at clinical office with symptoms of a DVT

Exclusion Criteria:

  • Pregnancy
  • Less than 18 years old
  • Non-English speaking
  • Chronic Deep Vein Thrombosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POCUS positive, High risk, STAT DVT
Patient who is high risk for DVT had a positive POCUS study in office was referred for STAT DVT study.
Diagnostic test: STAT Venous Duplex
STAT Venous Duplex
Experimental: POCUS positive, Low risk, STAT DVT
Patient who is low risk for DVT had a positive POCUS study in office was referred for STAT DVT study.
Diagnostic test: STAT Venous Duplex
STAT Venous Duplex
Experimental: POCUS negative, High risk, STAT DVT
Patient who is high risk for DVT had a negative POCUS study in office was referred for STAT DVT study.
Diagnostic test: STAT Venous Duplex
STAT Venous Duplex
Experimental: POCUS negative, Low risk, Routine DVT
Patient who is low risk for DVT had a negative POCUS study in office was referred for routine DVT study.
Diagnostic test: Routine Venous Duplex
Routine Venous Duplex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Have Identical POCUS Result to Venous Duplex Result
Time Frame: 1 week
Number of subjects whose ultrasound results using POCUS and subsequent confirmatory gold standard venous duplex ultrasound are identical, whether positive or negative for DVT.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Pulmonary Embolism
Time Frame: 3 months
Rate of morbidity will be monitored for 3 months following the diagnosis of DVT by confirmatory venous duplex. Rate of morbidity will be identified through emergency room visits related to the DVT and hospitalizations related to the DVT.
3 months
Rate of Stroke
Time Frame: 3 months
Rate of morbidity will be monitored for 3 months following the diagnosis of DVT by confirmatory venous duplex. Rate of morbidity will be identified through emergency room visits related to the DVT and hospitalizations related to the DVT.
3 months
Rate of Myocardial Infarction
Time Frame: 3 months
Rate of morbidity will be monitored for 3 months following the diagnosis of DVT by confirmatory venous duplex. Rate of morbidity will be identified through emergency room visits related to the DVT and hospitalizations related to the DVT.
3 months
Number of Subjects who Died
Time Frame: 3 months
Number of subjects who died will be monitored for 3 months following the diagnosis of DVT by confirmatory venous duplex.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00027831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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