A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
- CT-guided percutaneous lung nodule biopsy
Treatment groups
550 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov