Advanced Robotic Techniques for Lung Lesion Diagnosis

This study, called ARTEMIS, is looking at how well robotic-assisted bronchoscopy (a procedure using a thin tube with a camera to look inside your lungs) works to diagnose peripheral pulmonary lesions (PPLs), which are growths in the outer parts of your lungs. Researchers want to see if adding rapid onsite evaluation (ROSE), where biopsy samples are checked immediately during the procedure, improves diagnosis. You could join if you are 18 or older and are having a robotic-assisted bronchoscopy to biopsy a lung lesion. The study will measure how often enough tissue is collected for diagnosis within 7 days after the procedure. The current status of this study is unclear.

Study design
This is a multicenter randomized controlled trial with a planned enrollment of 400 participants. Participants will be assigned to either receive rapid onsite evaluation (ROSE) or not receive ROSE during their procedure.
What's involved
You will undergo a robotic-assisted bronchoscopy to biopsy a lung lesion. All decisions about the procedure and your care will be made by your treating physician.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured 7 days after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07685977

Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing.

Not Yet Recruiting
NAAges 18+InterventionalDiagnostic
Vanderbilt University Medical Center
~400 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Rapid onsite evaluation

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Strict diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
Measured over 7 days post procedure
Peripheral Pulmonary Lesions (PPLs)
8 sites across 7 states
Illinois2
Maryland1
Massachusetts1
New York1
North Carolina1
South Carolina1
Tennessee1
  • Fabien Maldonado, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 18 years of age at time of bronchoscopy
Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion

Exclusion

Declines to participate or inability to provide informed consent.
Clinician determination that the use of ROSE is required or contraindicated for the optimal care of an individual patient
Patient enrolled in another trial that requires ROSE for PPL biopsy
Patient previously consented for this trial
Pregnant or incarcerated patients
  • Strict diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.7 days post procedure

    Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified: 1. Malignancy 2. Specific benign pathologic findings including: organizing pneumonia, frank purulence/robust neutrophilic inflammation with a pathogen isolated, granulomatous inflammation, hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns.