NCT05562895

A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.

Detailed description

This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Ion Endoluminal System and Cios Spin	Integrated version of the Ion Endoluminal System and Cios Spin

Timeline

• Start date: 2022-12-31
• Primary completion: 2023-12-31
• Completion: 2025-08-31
• First posted: 2022-10-03
• Last updated: 2025-11-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study