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Focused Ultrasound of the Popliteal Fossa for Detection of Symptomatic Baker's Cysts in Patients With Suspected Deep Vein Thrombosis: A Pilot Diagnostic Accuracy Study

NCT07791017 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-08-27

No results posted yet for this study

Summary

Quality improvement study with prospective observational design. The study explores the feasibility of testing diagnostic accuracy of an emergency department-performed focused ultrasound scan of the popliteal fossa in detecting symptomatic Baker's cysts, and to evaluate the potential for such follow-ups to conserve radiological resources. Ultimately, this work aims to establish the feasibility and provide the foundational data necessary for a future definitive diagnostic accuracy study.

Conditions

  • Baker's Cyst

Interventions

DIAGNOSTIC_TEST

Index Test (Focused Ultrasound of the Popliteal Fossa)

Eligible patients will undergo a focused ultrasound examination of the popliteal fossa performed by a trained research assistant or emergency physician. The examination will be conducted before the results of D-dimer testing and CCUS are available. Operators will assess the presence and characteristics of Baker's cysts, evaluate whether an identified cyst is likely to explain the patient's presenting symptoms, estimate the probability of concurrent DVT, and complete a structured interpretation survey. FUP findings will be recorded for research purposes only and will not influence patient management.

DIAGNOSTIC_TEST

Reference test (Routine DVT Diagnostic Pathway)

Following FUP, all participants will proceed through the routine diagnostic pathway for suspected DVT. Depending on clinical probability and D-dimer results, patients may undergo no further testing or radiologist-performed complete compression ultrasound of the lower extremity (CCUS) according to standard practice. Final diagnoses established through the routine diagnostic pathway will serve as the reference standard.

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2026-10-09
Completion
2026-10-09

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07791017 on ClinicalTrials.gov