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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562895
• Other study ID #: ISI-ION-002
• Status: Recruiting
• Start date: December 31, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2023
• Source: Intuitive Surgical
• Contact: Alison Gorski
• Phone: 4085231855
• Email: alison.gorski[@]intusurg.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Multiple Pulmonary Nodules

Intervention

Device:
• Ion Endoluminal System and Cios Spin
Integrated version of the Ion Endoluminal System and Cios Spin

Locations

Country	Name	City	State
United States	South Austin Hospital	Austin	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied	Intra-procedure through the 13 month follow up period
Primary	Sensitivity for malignancy	Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy	Intra-procedure through the 13 month follow up period
Primary	Rate of tool in nodule	Tool in nodule is defined as any portion of the needle visualized within the target in all 3 axes (must be confirmed with 3D imaging)	Intra-procedure
Secondary	Total radiation dose	Radiation dose from biopsy procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm^2)	Intra-procedure
Secondary	Time to achieve tool in nodule	Defined as the time the Ion catheter crosses the endotracheal tube (ETT) to the time tool in nodule is confirmed with 3D imaging	Intra-procedure