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

Intuitive Surgical

Status: Active, not recruiting

Conditions: Lung Cancer

Treatments: Device: Ion Endoluminal System and Cios Spin

Study type: Observational

Funder types: Industry

Identifiers

NCT05562895

ISI-ION-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is 18 years or older at the time of the procedure.
• Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.
• Pulmonary nodule ≤2 cm in largest diameter.
• Subject able to understand and adhere to study requirements and provide informed consent.

Exclusion criteria

• Planned lymph node staging performed before nodule biopsy.
• Nodule is a pure ground glass opacity.
• Plan to biopsy multiple nodules.

Trial design

155 participants in 1 patient group

Subjects with biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin

Description:

Subjects in which a pulmonary nodule biopsy was attempted or performed with the integrated Ion Endoluminal System and Cios Spin

Treatment:

Device: Ion Endoluminal System and Cios Spin