Clinical trial NCT05562895: A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
Official title: A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2022-10-03
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with an attempted or performed pulmonary nodule biopsy using the Ion Endoluminal System and Cios Spin, 18 years or older

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic yield
timeFrame: Intra-procedure through the 13 month follow up period
measure: Sensitivity for malignancy
timeFrame: Intra-procedure through the 13 month follow up period
measure: Rate of tool in nodule
timeFrame: Intra-procedure
Secondary outcomes:
measure: Total radiation dose
timeFrame: Intra-procedure
measure: Time to achieve tool in nodule
timeFrame: Intra-procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: University of California San Diego, Hillcrest Medical Center
state: California
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Austin
country: United States
facility: South Austin Hospital
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson
name: Roberto Casal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Bryan Husta, MD
role: PRINCIPAL_INVESTIGATOR
References: