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 | Recruiting

• 1 other identifier: Baker's Cysts in DVT
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ultrasound; Venous thromboembolism; Popliteal cyst; Baker's cyst

Outcome Measures

Primary Outcomes (1)

• Participant recruitment rate

  Number of eligible patients enrolled per study month and proportion of eligible patients successfully enrolled.

  Immediately after the procedure

Secondary Outcomes (7)

• Completion rate of Focused Ultrasound of the Popliteal Fossa

  Immediately after the procedure

• Duration of the FUP examination

  Immediately after the procedure

• Diagnostic accuracy of FUP for detection of symptomatic Baker's cysts

  Immediately after the procedure

• Frequency of symptomatic Baker's cysts among patients evaluated for suspected DVT.

  Immediately after the procedure

• Concurrent DVT in participants with a symptomatic Baker's cyst identified on FUP

  Immediately after the procedure

Study Arms (1)

Patients with suspected deep vein thrombosis (DVT)

Adult patients referred to the Emergency Department at Aarhus University Hospital with suspected deep vein thrombosis and undergoing diagnostic evaluation with D-dimer testing and/or complete compression ultrasound of the lower extremity (CCUS) will be included consecutively.

Diagnostic Test: Index Test (Focused Ultrasound of the Popliteal Fossa); Diagnostic Test: Reference test (Routine DVT Diagnostic Pathway)

Interventions

Index Test (Focused Ultrasound of the Popliteal Fossa) DIAGNOSTIC_TEST

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.

Patients with suspected deep vein thrombosis (DVT)

Reference test (Routine DVT Diagnostic Pathway) DIAGNOSTIC_TEST

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.

Patients with suspected deep vein thrombosis (DVT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients referred to the Emergency Department at Aarhus University Hospital with suspected deep vein thrombosis and undergoing diagnostic evaluation with D-dimer testing and/or complete compression ultrasound of the lower extremity will be included consecutively.

You may qualify if:

• Age ≥ 18 years
• Clinical signs and symptoms of DVT, prompting the treating physician to initiate d-Dimer or CCUS diagnostic strategies

You may not qualify if:

• FUP performed following d-Dimer or CCUS result already revealed

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

MeSH Terms

Conditions

Popliteal Cyst; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Synovial Cyst; Cysts; Neoplasms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): October 9, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)