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

A Randomized Controlled Trial Evaluating Lung Nodules - COMparing Percutaneous CT-Guided Biopsy And Shape-Sensing Robotic-Assisted Bronchoscopy (ENCOMPASS)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer (Diagnosis); Lung Nodule
• Intervention / Treatment: Procedure: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT); Procedure: CT-guided percutaneous lung nodule biopsy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carine Van den Abeele; Phone Number: +41 21 821 2000; Email: Encompass@intusurg.com
• Study Contact Backup: Name: Martha Bean; Phone Number: +41 21 821 2000; Email: Encompass@intusurg.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patient has previously undergone a biopsy procedure of the target nodule by any approach.
2. Patient was previously randomized in this study but did not undergo biopsy.
3. 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.
4. Patient is pregnant or breastfeeding as determined by standard site practices.
5. 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.
6. Patient is not willing to comply with study participation requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT); A 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.; Other Names: ssRAB; Ion endoluminal system
Active Comparator: CT-Guided Percutaneous Lung Nodule Biopsy; Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.	Procedure: CT-guided percutaneous lung nodule biopsy; A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.; Other Names: Transthoracic Needle Aspiration (TTNA); Transthoracic Needle Biopsy (TTNB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the index procedure
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.	From procedure to 7 days (or until subsequent intervention, whichever occurs first).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield	Diagnostic yield of the index biopsy procedure, defined according to American Thoracic Society (ATS) and American College of Chest Physicians (ACCP) guidance	At the index procedure
Sensitivity for Malignancy	Sensitivity of the index biopsy procedure for the diagnosis of malignancy, based on final diagnosis established through 1-year follow-up	Through 1 year post-procedure
Negative Predictive Value	Negative predictive value of the index biopsy procedure based on final diagnosis established through 1-year follow-up	Through 1 year post-procedure
Diagnostic accuracy	Diagnostic accuracy of the index biopsy procedure based on final diagnosis established through 1-year follow-up.	Through 1 year post-procedure
Adequacy of Specimen for Molecular and/or Immunohistochemistry Testing	Proportion of biopsy specimens considered adequate for molecular profiling and/or immunohistochemistry (IHC) testing.	At the index procedure
Procedure-Related Adverse Events	Incidence of procedure-related adverse events.	Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
Procedure-related serious adverse events.	Incidence of procedure-related serious adverse events.	Through 30 days post-procedure or until the first invasive diagnostic or therapeutic intervention, whichever occurs first
All-Cause Mortality	Incidence of all-cause mortality among study participants.	Through study exit
Length of Stay for Procedure-Related Adverse Events	Duration of hospitalization attributable to procedure-related adverse events	From the date of hospitalization for a procedure-related adverse event until hospital discharge, for events occurring up to 30 days following the index procedure

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Ricky Thakrar, MD, University College London Hospitals; Principal Investigator: Neal Navani, MD, University College London Hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bronchoscopy; Lung Biopsy; Pulmonary Nodules; CT-Guided Percutaneous Biopsy; Robotic-Assisted Bronchoscopy; Shape-Sensing Robotic-Assisted Bronchoscopy (ssRAB); Transthoracic Needle Aspiration (TTNA)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease; Multiple Pulmonary Nodules
• Other Study ID Numbers: ISI-RCT-EU4-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes