A prospective, single-center investigation of the safety and feasibility of a novel Microwave Ablation System

Intuitive Surgical0 sites30 target enrollmentSeptember 7, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 7, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Subject has ASA \< 4
•\-\-Subject is not a candidate for surgical resection of lung tumor (e.g. subject has medically inoperable lung cancer based on subject condition or tumor/disease characteristic) or patient refuses surgery
•\-\-Subject with a solid or semi\-solid primary or secondary lung tumor of 0\.8 \-2\.5 cm in largest diameter
•\-\-Subject has ECOG score \< 2
•\-\-Subject has a confirmed diagnosis of Stage I\-IIIA lung cancer with no evidence of nodal disease OR oligometastatic disease with secondary lung tumors (e.g., a primary cancer that developed at other places in the body or other parts of the lungs and metastasized to the lung where intervention is considered)
•\-\-Subject is a candidate for an elective bronchoscopy procedure under general anesthesia
•\-\-Target lesion is located in bronchial generation 3\+ (segmental or beyond), with the trachea representing generation 0 as assessed on pre\-procedure CT scan
•\-\-Subject is willing and able to provide written informed consent
•\-\-Subject is willing and able to comply with the study protocol requirements

•\-\-Subject is unable to have intravenous contrast injection
•\-\-Baseline FEV1 \< 40% and/or DLCO \< 40% if clinically relevant per investigator assessment (e.g. represents risk to subjects undergoing procedure)
•\-\-Subject had any COPD exacerbation within 6 weeks of procedure
•\-\-Subject had a prior surgical procedure or therapeutic intervention (e.g. SBRT) within same lobe as the lesion
•\-\-Target lesion edge is within 1 cm of critical structures (e.g. esophagus, heart, aorta, or major vasculature) or within 0\.5 cm of non\-fissure parietal/visceral pleura
•\-\-Subject on a medication that interferes with clotting, including but not limited to Coumadin, Lovenox, or Plavix that cannot be stopped at least 7 days prior to the procedure and at least 3 days after procedure
•\-\-Subjects with Creatinine levels \> 2\.0
•\-\-Subjects with platelet count \< 80,000
•\-\-Subjects with documented history of CHILD\-PUGH Class B or Class C liver disease
•\-\-Subject has a planned therapeutic intervention (e.g. chemotherapy) for a malignant condition post\-procedure