A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy

CT-guided percutaneous biopsy and ssRAB with CBCT are two types of lung nodule biopsy procedures routinely used in clinical practice. The study is designed to evaluate the diagnostic efficacy and safety of ssRAB with CBCT compared with CT-guided percutaneous lung nodule biopsy in adults requiring diagnostic evaluation of a pulmonary nodule. The co-primary objectives are to assess non-inferiority of diagnostic efficacy and superiority of safety.

The primary endpoints are diagnostic efficacy and the rate of peri-procedural pneumothorax (with or without intervention) associated with the assigned biopsy approach.

Eligible participants will be randomized 1:1 to either ssRAB with CBCT or CT-guided percutaneous lung nodule biopsy. If the clinical team determines that the assigned procedure is not suitable, the participant will receive the most appropriate standard of care instead. Both biopsy procedures will be performed according to routine clinical practice, and no experimental devices or procedures will be used.

Participants will be followed for up to 12 months through medical record review and routine clinical follow-up. Patient-reported quality of life and, optionally, work status will be assessed using questionnaires at multiple time points. No research-specific assessments, burdensome tests, or advanced imaging outside of standard care will be performed. A chest X-ray will be required following the biopsy procedure, consistent with routine clinical practice.

Inclusion criteria

• Patient is aged 18 years or older at time of consent.
• Diagnostic nodule biopsy(s) indicated per multidisciplinary team (or equivalent).
• Target pulmonary nodule ≤2 cm in largest diameter.
• Patient is willing and able to give written informed consent for clinical study participation.

Exclusion criteria

• Patient has previously undergone a biopsy procedure of the target nodule by any approach.
• Patient was previously randomized in this study but did not undergo biopsy.
• Patient is participating in an interventional research study or research study with investigational agents with an unknown safety profile that would interfere with participation in this study or study results.
• Patient is pregnant or breastfeeding as determined by standard site practices.
• Patient lacks the capacity to provide informed consent for themselves, or is a vulnerable patient whose ability to protect their own interests or to consent freely may be diminished, including but not limited to, patients who may be unduly influenced through dependency on the sponsor, the hospital, or the study doctor.
• Patient is not willing to comply with study participation requirements.