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

NCT07761351 | Not Yet Recruiting Phase 4 DMC FDA Device

• 1 other identifier: ISI-RCT-EU4-2025
• Study Type: interventional
• Target: 550
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Lung Cancer (Diagnosis); Lung Nodule

Keywords

Lung Biopsy; CT-Guided Percutaneous Biopsy; Robotic-Assisted Bronchoscopy; Shape-Sensing Robotic-Assisted Bronchoscopy (ssRAB); Transthoracic Needle Aspiration (TTNA); Bronchoscopy; Pulmonary Nodules

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Diagnostic Yield

  At the index procedure

• Sensitivity for Malignancy

  Through 1 year post-procedure

• Negative Predictive Value

  Through 1 year post-procedure

• Diagnostic accuracy

  Through 1 year post-procedure

• Adequacy of Specimen for Molecular and/or Immunohistochemistry Testing

  At the index procedure

Study Arms (2)

Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)

ACTIVE COMPARATOR

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)

CT-Guided Percutaneous Lung Nodule Biopsy

ACTIVE COMPARATOR

Participants randomized to pulmonary nodule biopsy using a CT-guided percutaneous biopsy approach.

Procedure: CT-guided percutaneous lung nodule biopsy

Interventions

Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT) PROCEDURE

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.

Also known as: ssRAB, Ion endoluminal system

Shape-Sensing Robotic-Assisted Bronchoscopy with Cone-Beam CT (ssRAB with CBCT)

CT-guided percutaneous lung nodule biopsy PROCEDURE

A percutaneous lung nodule biopsy procedure performed under CT imaging guidance according to standard clinical practice.

Also known as: Transthoracic Needle Aspiration (TTNA), Transthoracic Needle Biopsy (TTNB)

CT-Guided Percutaneous Lung Nodule Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intuitive Surgical: lead

MeSH Terms

Conditions

Lung Neoplasms; Disease; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricky Thakrar, MD

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

• Neal Navani, MD

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carine Van den Abeele

CONTACT

+41 21 821 2000; Encompass@intusurg.com

Martha Bean

CONTACT

+41 21 821 2000; Encompass@intusurg.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share