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

NCT07761351 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2026-08-12

No results posted yet for this study

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

Interventions

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.

PROCEDURE

CT-guided percutaneous lung nodule biopsy

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

Sponsors & Collaborators

  • Intuitive Surgical

    lead INDUSTRY

Principal Investigators

  • Ricky Thakrar, MD · University College London Hospitals

  • Neal Navani, MD · University College London Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-04-30
Completion
2029-04-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761351 on ClinicalTrials.gov