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

Not Applicable

• Conditions: C34; C78.0; Malignant neoplasm of bronchus and lung; Secondary malignant neoplasm of lung

• Registration Number: DRKS00032463
• Lead Sponsor: Intuitive Surgical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

--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
--Clinically significant pulmonary fibrosis or interstitial lung disease in target region expected to interfere with the planned ablation zone per investigator assessment
--Lesion has significant necrosis, and which may disrupt planned ablation zone per investigator assessment. Note – if significant necrosis or cavitation is noted during the procedure but prior to attempted probe placement, the subject will be excluded.
--Patient has nodal disease confirmed through invasive or image-based staging per investigator assessment precluding surgical resection or neoadjuvant therapy will be administered prior to the study procedure or planned resection. Note – if unexpected nodal disease is detected during the staging procedure conducted prior to use of the Investigational device during the study procedure; the subject may be excluded.
--Clinically significant emphysematous disease such as bulla/blebs in the same lobe as the target lesion or per Investigator assessment
--Subject with uncorrectable coagulopathy, bleeding or platelet disorders, or history of major bleeding with bronchoscopy
--Subject had a prior pneumonectomy
--Subject has clinically suspected or documented pulmonary hypertension
--Subject had a therapeutic intervention (e.g. SBRT) within same lobe as the target lesion
--Subject presents with documented life-threatening comorbidity that may increase risk of bronchoscopic procedure, including but not limited to Congestive Heart Failure or any type of Myocardial infarction (within 3 months of the procedure)
--Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment or radiotherapy within 3 months of planned Study procedure
--Patients with recent pulmonary infection requiring antibiotics or hospitalization, or clinically relevant infectious disease within 30 days of the study procedure.
--Patient has active COVID-19 infection or post-COVID induced lung changes on CT which are clinically significant per investigator assessment
--Participation in any other interventional clinical study within 30 days prior of screening that interferes with or may confound safety or feasibility assessments
--Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements --
--Subject with any electronic implantable devices, such as pacemakers
--Subject is pregnant, suspected to be pregn

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
--Incidence of pneumothorax requiring intervention (occurring within 48 hours of the study procedure) or excessive peri-procedural bronchopulmonary bleeding (e.g. airway bleeding requiring selective intubation, transfusion, premature termination of procedure or change in level of care) related to the investigational device or study procedure; <br>--Deployment Success – imaging confirmation ablation probe is deployed within the target lesion and positioned for ablation. Successful deployment location may be within the target lesion, or intentionally adjacent to the lesion for the purposes including but not limited to bracketing; <br>--Procedural success - completion of intended ablation per protocol – Confirmed energy delivery measured by probe temperature during ablation; <br>--Technique Success – Radiographic evidence of ablation induced changes to the target lesion (e.g. appearance of ground glass opacification around the target lesion) within approximately 30 days

Secondary Outcome Measures

Name	Time	Method
--Local recurrence rate evaluated through 24 months post-procedure. Local recurrence will be confirmed through a tissue biopsy of the target lesion, or as determined by the Multidisciplinary Therapeutic/Tumor Board based on radiographic follow-up and clinical information, or if treatment is pursued for malignancy in target lesion<br>--Subject quality of life, as measured through the EORTC-QLQ-C30, EORTC-QLQ-LC13 and EuroQoL EQ-5D-5L questionnaires at 30 days, 3 months, 6 months, 12 months, 18 months and 24 months post-procedure <br>--Rate of subjects with disease progression (local control) through 12 and 24 months <br>--Progression free survival through 24 months<br>--Lesion characteristics on post-procedure imaging through 24 months (stable, growth or reduction relative to 3m CT)