A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntuitive Surgical
About this trial
The ENCOMPASS study is a post-market, multicenter, randomized controlled trial comparing two established approaches for obtaining a biopsy of small pulmonary nodules (≤2 cm): CT-guided percutaneous lung nodule biopsy and shape-sensing robotic-assisted bronchoscopy with cone-beam CT (ssRAB with CBCT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
Procedure/SurgeryA bronchoscopic lung nodule biopsy procedure performed using shape-sensing robotic-assisted bronchoscopy with cone-beam CT guidance as clinically indicated and according to standard clinical practice.
CT-guided percutaneous lung nodule biopsy
Procedure/SurgeryA percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.
Treatment groups
550 Participants
are divided into 2 treatment groupsGroup A: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)Active comparator 1 intervention
Group B: CT-Guided Percutaneous Lung Nodule BiopsyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic Efficacy of the Assigned Biopsy Procedure
Diagnostic efficacy will be calculated as the proportion of patients who receive their assigned treatment multiplied by diagnostic yield of their assigned treatment.
Time frame
At the index procedure2
Peri-Procedural Pneumothorax Rate
Rate of peri-procedural pneumothorax related to the assigned index biopsy procedure, including pneumothorax identified on routine post-procedure imaging and clinically relevant pneumothorax requiring intervention or escalation of care.
Time frame
From procedure to 7 days (or until subsequent intervention, whichever occurs first).Secondary outcomes
1
Diagnostic Yield
Diagnostic yield of the index biopsy procedure, defined according to American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) guidance
Time frame
At the index procedure2
Sensitivity for Malignancy
Sensitivity of the index biopsy procedure for the diagnosis of malignancy, based on final diagnosis established through 1-year follow-up
Time frame
Through 1 year post-procedure3
Negative Predictive Value
Negative predictive value of the index biopsy procedure based on final diagnosis established through 1-year follow-up
Time frame
Through 1 year post-procedure4
Diagnostic accuracy
Diagnostic accuracy of the index biopsy procedure based on final diagnosis established through 1-year follow-up.
Time frame
Through 1 year post-procedureSponsors and contacts
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Source ClinicalTrials.gov