NCT07400510

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Mar 2026Aug 2027

First Submitted

Initial submission to the registry

January 28, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

January 28, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

POCUSDVTDeep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Who Have Identical POCUS Result to Venous Duplex Result

    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 Outcomes (4)

  • Rate of Pulmonary Embolism

    3 months

  • Rate of Stroke

    3 months

  • Rate of Myocardial Infarction

    3 months

  • Number of Subjects who Died

    3 months

Study Arms (4)

POCUS positive, High risk, STAT DVT

EXPERIMENTAL

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

POCUS positive, Low risk, STAT DVT

EXPERIMENTAL

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

POCUS negative, High risk, STAT DVT

EXPERIMENTAL

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

POCUS negative, Low risk, Routine DVT

EXPERIMENTAL

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

Interventions

STAT Venous DuplexDIAGNOSTIC_TEST

STAT Venous Duplex

POCUS negative, High risk, STAT DVTPOCUS positive, High risk, STAT DVTPOCUS positive, Low risk, STAT DVT
Routine Venous DuplexDIAGNOSTIC_TEST

Routine Venous Duplex

POCUS negative, Low risk, Routine DVT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Health, Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Family & Community Medicine

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 10, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations