A Randomized Controlled Trial Evaluating Lung Nodules - COMparing Percutaneous CT-Guided Biopsy And Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Switzerland
Basel University Hospital
RECRUITING
Basel
United Kingdom
University College London Hospitals NHS Foundation
RECRUITING
London
Contact Information
Primary
Carine Van den Abeele
Encompass@intusurg.com
+41 21 821 2000
Backup
Martha Bean
Encompass@intusurg.com
+41 21 821 2000
Time Frame
Start Date: 2026-08-28
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 550
Treatments
Active_comparator: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)
Participants randomized to pulmonary nodule biopsy using shape-sensing robotic-assisted bronchoscopy with cone-beam CT.
Active_comparator: CT-Guided Percutaneous Lung Nodule Biopsy
Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.
Related Therapeutic Areas
Sponsors
Leads: Intuitive Surgical