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A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB

NCT06308120 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2026-04-06

No results posted yet for this study

Summary

Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules.

Conditions

Interventions

DEVICE

Ion Endoluminal System

Participants in the test arm will undergo a diagnostic bronchoscopy with ION™ Endoluminal System.

DEVICE

superDimension Navigation System and Accessories

Participants in the control arm will undergo a diagnostic bronchoscopy with superDimension Navigation System and Accessories.

Sponsors & Collaborators

  • Intuitive Surgical-Fosun Medical Technology (Shanghai) Co., Ltd

    collaborator UNKNOWN

  • Intuitive Surgical

    lead INDUSTRY

Principal Investigators

  • Jiayuan Sun, M.D. · Shanghai Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2026-12-30
Completion
2027-01-30
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06308120 on ClinicalTrials.gov