Deep Venous ThrombosesNCT07400510
DVT Evaluation Using POCUS for Diagnosis and Treatment
A study testing STAT Venous Duplex and Routine Venous Duplex in people with Deep Venous Thromboses, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Thromboses
- What is being tested?
- STAT Venous Duplex and Routine Venous Duplex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Penn State health patient
- 18 years and older
- English speaking
- Presentation at clinical office with symptoms of a DVT
Who cannot join
- Pregnancy
- Less than 18 years old
- Non-English speaking
- Chronic Deep Vein Thrombosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Penn State Health, Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
- Conditions
- Deep Venous Thromboses
- Being tested
- STAT Venous Duplex, Routine Venous Duplex
- Keywords
- POCUS, DVT, Deep Vein Thrombosis
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAT Venous DuplexDiagnostic test
STAT Venous Duplex
Routine Venous DuplexDiagnostic test
Routine Venous Duplex
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Routine Venous Duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (4)
Rate of Pulmonary Embolism
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.
Measured: 3 months
Rate of Stroke
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.
Measured: 3 months
Rate of Myocardial Infarction
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.
Measured: 3 months
Number of Subjects who Died
Number of subjects who died will be monitored for 3 months following the diagnosis of DVT by confirmatory venous duplex.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Mar 2026
- Primary completion30 May 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie A. Carey, MD, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400510
- Sponsor's protocol ID
- STUDY00027831
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Lower Extremity DVT Outcomes in the Outpatient Setting: An Evaluation of 3-Point of Care Ultrasound for Timely Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT07400510
- Acronym / sponsor ID
- STUDY00027831
- Conditions
- Deep Venous Thromboses
- Keywords
- POCUS, DVT, Deep Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| POCUS positive, High risk, STAT DVT | Experimental | Diagnostic Test: STAT Venous DuplexPatient who is high risk for DVT had a positive POCUS study in office was referred for STAT DVT study. |
| POCUS positive, Low risk, STAT DVT | Experimental | Diagnostic Test: STAT Venous DuplexPatient who is low risk for DVT had a positive POCUS study in office was referred for STAT DVT study. |
| POCUS negative, High risk, STAT DVT | Experimental | Diagnostic Test: STAT Venous DuplexPatient who is high risk for DVT had a negative POCUS study in office was referred for STAT DVT study. |
| POCUS negative, Low risk, Routine DVT | Experimental | Diagnostic Test: Routine Venous DuplexPatient who is low risk for DVT had a negative POCUS study in office was referred for routine DVT study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Penn State health patient
- 18 years and older
- English speaking
- Presentation at clinical office with symptoms of a DVT
Key exclusion criteria (4 listed)
- Pregnancy
- Less than 18 years old
- Non-English speaking
- Chronic Deep Vein Thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAT Venous DuplexSTAT Venous Duplex | Diagnostic test | POCUS negative, High risk, STAT DVT, POCUS positive, High risk, STAT DVT, POCUS positive, Low risk, STAT DVT |
| Routine Venous DuplexRoutine Venous Duplex | Diagnostic test | POCUS negative, Low risk, Routine DVT |
Primary outcome
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.
4 secondary outcomes
Rate of Pulmonary Embolism
Time frame: 3 months
Rate of Stroke
Time frame: 3 months
Rate of Myocardial Infarction
Time frame: 3 months
Number of Subjects who Died
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
Pregnancy Related, Deep Vein Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAT Venous Duplex and Routine Venous Duplex in people with Deep Venous Thromboses, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Have Identical POCUS Result to Venous Duplex Result (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.