Baker's CystBAKER-DVTNCT07791017
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
An observational study of Baker's Cyst, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Baker's Cyst
- What is being tested?
- Index Test (Focused Ultrasound of the Popliteal Fossa) and Reference test (Routine DVT Diagnostic Pathway)
- How many people
- 94 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Aug 2026to 9 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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.
Who may be able to join
- Age ≥ 18 years
- Clinical signs and symptoms of DVT, prompting the treating physician to initiate d-Dimer or CCUS diagnostic strategies
Who cannot join
- Prior inclusion
- FUP performed following d-Dimer or CCUS result already revealed
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the detailed description
Patients with suspected deep vein thrombosis (DVT) are commonly evaluated using clinical probability assessment, D-dimer testing, and compression ultrasonography. However, a substantial proportion of patients referred for DVT evaluation are ultimately diagnosed with alternative conditions that may explain their symptoms. One such condition is a symptomatic Baker's cyst, which may present with unilateral leg pain, swelling, or discomfort that clinically mimics DVT.
In current clinical practice, radiologist-performed complete compression ultrasound of the lower extremity (CCUS) is primarily used to confirm or exclude DVT. Although Baker's cysts are frequently identified during these examinations, their potential role as an early alternative diagnosis within the diagnostic pathway has not been systematically investigated. A focused ultrasound examination of the popliteal fossa (FUP) may allow emergency department (ED) or primary care clinicians to identify symptomatic Baker's cysts before referral for further DVT workup.
This prospective pilot study primarily aims to evaluate the feasibility of conducting a future definitive study investigating the role of FUP in patients with suspected DVT. Key feasibility outcomes include recruitment rates, scan completion rates, workflow integration, procedure timing, and practical implementation within routine emergency care. In addition, the study will generate preliminary diagnostic accuracy estimates regarding the ability of ED physicians and trained research assistants to identify symptomatic Baker's cysts using FUP, with CCUS serving as the reference standard. These data will be used to estimate outcome variance and inform sample size calculations and study design for a future definitive validation study.
This single-center pilot study will be conducted at Aarhus University Hospital, Denmark, among adult patients referred to the ED with suspected DVT. All participants will receive standard diagnostic evaluation and management according to current guidelines. The study-specific FUP examination will be performed before D-dimer and/or CCUS results are available, and FUP findings will not influence clinical decision-making during the study.
- Conditions
- Baker's Cyst
- Being tested
- Index Test (Focused Ultrasound of the Popliteal Fossa), Reference test (Routine DVT Diagnostic Pathway)
- Keywords
- Ultrasound, Venous thromboembolism, Popliteal cyst, Baker's cyst
- Medical subject headings
- Popliteal Cyst, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Index Test (Focused Ultrasound of the Popliteal Fossa); Diagnostic Test: Reference test (Routine DVT Diagnostic Pathway) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment rate
Number of eligible patients enrolled per study month and proportion of eligible patients successfully enrolled.
Measured: Immediately after the procedure
Secondary outcomes (7)
Completion rate of Focused Ultrasound of the Popliteal Fossa
Proportion of initiated FUP examinations successfully completed and deemed interpretable.
Measured: Immediately after the procedure
Duration of the FUP examination
Time required to perform and document the FUP examination.
Measured: Immediately after the procedure
Diagnostic accuracy of FUP for detection of symptomatic Baker's cysts
Sensitivity, specificity, positive predictive value, and negative predictive value of FUP compared with radiologist-performed complete compression ultrasound of the lower extremity (CCUS).
Measured: Immediately after the procedure
Frequency of symptomatic Baker's cysts among patients evaluated for suspected DVT.
Proportion of participants with a symptomatic Baker's cyst identified on FUP.
Measured: Immediately after the procedure
Concurrent DVT in participants with a symptomatic Baker's cyst identified on FUP
Proportion of participants with a symptomatic Baker's cyst on FUP who are subsequently diagnosed with DVT through the routine diagnostic pathway.
Measured: Immediately after the procedure
Estimated impact of FUP on clinical decision-making
Proportion of examinations in which the operator indicates that the FUP finding would have altered the estimated post-test probability of DVT or influenced further diagnostic workup.
Measured: Immediately after the procedure
Ultrasound image quality
Proportion of FUP examinations rated as of adequate diagnostic quality upon retrospective review by a proficient radiologist.
Measured: Within 60 days of the index examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start3 Aug 2026
- Primary completion9 Oct 2026
- Study completion9 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baker's CystStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stig Holm Ovesen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791017
- Sponsor's protocol ID
- Baker's Cysts in DVT
- Acronym
- BAKER-DVT
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets will not be shared due to legal and privacy restrictions associated with data approved for use in a quality improvement study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07791017
- Acronym / sponsor ID
- BAKER-DVT / Baker's Cysts in DVT
- Conditions
- Baker's Cyst
- Keywords
- Ultrasound, Venous thromboembolism, Popliteal cyst, Baker's cyst
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 9 Oct 2026 (actual)
- Study completion
- 9 Oct 2026 (actual)
- First posted
- 27 Aug 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.
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.
Detailed description
Patients with suspected deep vein thrombosis (DVT) are commonly evaluated using clinical probability assessment, D-dimer testing, and compression ultrasonography. However, a substantial proportion of patients referred for DVT evaluation are ultimately diagnosed with alternative conditions that may explain their symptoms. One such condition is a symptomatic Baker's cyst, which may present with unilateral leg pain, swelling, or discomfort that clinically mimics DVT.
In current clinical practice, radiologist-performed complete compression ultrasound of the lower extremity (CCUS) is primarily used to confirm or exclude DVT. Although Baker's cysts are frequently identified during these examinations, their potential role as an early alternative diagnosis within the diagnostic pathway has not been systematically investigated. A focused ultrasound examination of the popliteal fossa (FUP) may allow emergency department (ED) or primary care clinicians to identify symptomatic Baker's cysts before referral for further DVT workup.
This prospective pilot study primarily aims to evaluate the feasibility of conducting a future definitive study investigating the role of FUP in patients with suspected DVT. Key feasibility outcomes include recruitment rates, scan completion rates, workflow integration, procedure timing, and practical implementation within routine emergency care. In addition, the study will generate preliminary diagnostic accuracy estimates regarding the ability of ED physicians and trained research assistants to identify symptomatic Baker's cysts using FUP, with CCUS serving as the reference standard. These data will be used to estimate outcome variance and inform sample size calculations and study design for a future definitive validation study.
This single-center pilot study will be conducted at Aarhus University Hospital, Denmark, among adult patients referred to the ED with suspected DVT. All participants will receive standard diagnostic evaluation and management according to current guidelines. The study-specific FUP examination will be performed before D-dimer and/or CCUS results are available, and FUP findings will not influence clinical decision-making during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected deep vein thrombosis (DVT) | – | Diagnostic Test: Index Test (Focused Ultrasound of the Popliteal Fossa), Diagnostic Test: Reference test (Routine DVT Diagnostic Pathway)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Clinical signs and symptoms of DVT, prompting the treating physician to initiate d-Dimer or CCUS diagnostic strategies
Key exclusion criteria (2 listed)
- Prior inclusion
- FUP performed following d-Dimer or CCUS result already revealed
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 |
|---|---|---|
| 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 | Patients with suspected deep vein thrombosis (DVT) |
| 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. | Diagnostic test | Patients with suspected deep vein thrombosis (DVT) |
Primary outcome
Participant recruitment rate
Time frame: Immediately after the procedure
Number of eligible patients enrolled per study month and proportion of eligible patients successfully enrolled.
7 secondary outcomes
Completion rate of Focused Ultrasound of the Popliteal Fossa
Time frame: Immediately after the procedure
Duration of the FUP examination
Time frame: Immediately after the procedure
Diagnostic accuracy of FUP for detection of symptomatic Baker's cysts
Time frame: Immediately after the procedure
Frequency of symptomatic Baker's cysts among patients evaluated for suspected DVT.
Time frame: Immediately after the procedure
Concurrent DVT in participants with a symptomatic Baker's cyst identified on FUP
Time frame: Immediately after the procedure
Estimated impact of FUP on clinical decision-making
Time frame: Immediately after the procedure
Ultrasound image quality
Time frame: Within 60 days of the index examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No. The datasets will not be shared due to legal and privacy restrictions associated with data approved for use in a quality improvement study.
Related trials for Baker's Cyst
Not yet recruiting
"The Importance of Adding Fenestration to Ultrasound-Guided Baker's Cyst Aspiration"
Baker Cyst, Fenestration
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. This study is not recruiting at the moment.
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?
An observational study of Baker's Cyst, run by Aarhus University Hospital at 1 site in Denmark.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 28 Oct 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant recruitment rate (time frame: Immediately after the procedure). 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 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.