NCT06004440

Real World Registry for Use of the Ion Endoluminal System

A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.

Detailed description

This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield. Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.

Conditions

• Lung Cancer
• Multiple Pulmonary Nodules
• Lung Neoplasms
• Respiratory Tract Neoplasms
• Thoracic Neoplasms
• Neoplasms by Site
• Neoplasms
• Lung Diseases
• Respiratory Tract Diseases

Interventions

Type	Name	Description
DEVICE	Ion Endoluminal System	Subjects will under a planned procedure with the Ion Endoluminal System

Timeline

• Start date: 2023-09-21
• Primary completion: 2029-08-01
• Completion: 2030-08-01
• First posted: 2023-08-22
• Last updated: 2025-11-13

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study