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RECRUITING
NCT07791017

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

Sponsor: Aarhus University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-08-03

Completion Date

2026-10-09

Last Updated

2026-08-27

Healthy Volunteers

No

Conditions

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.

Locations (1)

Aarhus University Hospital

Aarhus, Denmark