NCT06923774

European Real-World Registry for Use of the Ion Endoluminal System

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to collect collect real-world data for the Ion endoluminal system.

Detailed description

This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.

Conditions

• Pulmonary Nodule
• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Ion endoluminal system	Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care

Timeline

• Start date: 2025-09-09
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2025-04-11
• Last updated: 2026-03-24

Locations

5 sites across 4 countries: France, Germany, Switzerland, United Kingdom