PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System

Intuitive Surgical6 sites in 1 country365 target enrollmentMarch 29, 2019

ConditionsPulmonary Nodule Lung Cancer Lung Diseases

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pulmonary Nodule
Sponsor: Intuitive Surgical
Enrollment: 365
Locations: 6
Primary Endpoint: Navigation Success
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System ("Ion") for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.

Registry

clinicaltrials.gov

Start Date

March 29, 2019

End Date

May 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Intuitive Surgical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged 18 years and older
•Patient is suitable for elective bronchoscopy
•Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease
•Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤ 3cm in largest dimension
•Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus\*
•Patients are candidates for CT-guided needle biopsy and/or surgical resection
•Patient able to understand and adhere to study requirements
•Patient able to understand and adhere to study requirements and able to provide informed consent
•Patient not legally incapacitated or in legal/court ordered institution
•Patients with no dependency on the investigator or sponsor

Exclusion Criteria

•Lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure
•Acute myocardial infarction or unstable angina ≤ 6 weeks prior to study procedure
•Clinically relevant partial trachea obstruction or obstruction of vena cava per physician assessment
•Acute respiratory failure, clinically significant hypoxemia, or high respiratory rate (i.e.\> 30 breaths per minute) per physician assessment)
•Renal insufficiency that presents risk per physician's discretion or liver failure (i.e. CHILD-PUGH Class C)
•World Health Organization functional Class III or Class IV Pulmonary Hypertension or history of clinically significant mPAP
•Lung abscess
•Known or suspected pregnancy
•Recent head injury (\<12 weeks pre-procedure) or subjects presenting with clinically significant neurologic deficits
•Unstable hemodynamic status (i.e. Dysrhythmia requiring intervention, altered mental status/consciousness)