Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

NCT ID: NCT06158971

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2025-01-31

Brief Summary

Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.

Detailed Description

This study is a prospective, single-arm, single-center, study to evaluate the safety and technical feasibility of using the phenoWave MW Ablation System to deliver microwave energy for ablation of lesions in the lung.

Conditions

Lung Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Flexible Microwave Ablation

Soft tissue ablation will be performed using the phenoWave flexible Microwave Ablation System and Accessories on lesions in the peripheral lung. The image-guided ablation procedure may utilize a combination of the radial EBUS and conebeam CT to confirm the lesion, position of the device relative to lesion and monitor the ablation progress.

Group Type: EXPERIMENTAL

Flexible Bronchoscopic Microwave Ablation

Intervention Type: DEVICE

The phenoWave flexible microwave ablation system will be used to perform soft tissue ablation in the lungs under image guidance.

Interventions

Flexible Bronchoscopic Microwave Ablation

The phenoWave flexible microwave ablation system will be used to perform soft tissue ablation in the lungs under image guidance.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 45-77 years at screening.
• Confirmed NSCLC or solitary metastatic (oligometastatic) or pulmonary metastases from an extra thoracic primary tumor lung nodule through diagnostic biopsy
• Must be eligible for curative lung resection (lobectomy).
• For primary tumor, pre-ablated parenchymal tumor/lesion size ≥ 20 mm if NSCLC, or ≥ 10 mm for metastatic disease in diameter as measured from pre-operative CT image.
• Willing to participate in all aspects of study protocol for duration of study.
• Able to understand study requirements.
• Signs informed consent form.
• Boundary of tumor is at least 15 mm away from the pleura wall and/or fissure.

Exclusion Criteria

• Any contraindication to bronchoscopy, for example:

• Untreatable life-threatening arrhythmias.
• Inability to adequately oxygenate the patient during the procedure.
• Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated).
• Recent myocardial infarction.
• Uncorrectable coagulopathy.
• Known coagulopathy.
• Platelet dysfunction or platelet count < 100 x 109 cells/L OR taking anticoagulant or antiplatelet agents that cannot be safely ceased in the opinion of the pulmonologist or surgeon.
• History of major bleeding with bronchoscopy.
• Suspected pulmonary hypertension.
• Moderate-to-severe pulmonary fibrosis.
• Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD) within 3cm of tumor/lesion boundary: prior COPD assessment data is evaluated and PI consent is required.
• Bullae >5 centimeter (cm) located in vicinity of target tumor/lesion.
• Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic MWA, for example:

• American Society of Anesthesiologists (ASA) physical status classification >P3
• Stage 3 heart failure
• Severe cachexia
• Severe respiratory insufficiency or hypoxia
• Ongoing systemic infection.
• Contraindication to general anesthesia.
• Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure.
• Participation in any other study in last 30 days.
• Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
• Life expectancy of less than 6 months.
• Prior radiation therapy treatment in the target lobe.
• Implantable pacemaker or defibrillator.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NIH/NCI - Grant award number: R01CA218357

UNKNOWN

Sponsor Role: collaborator

phenoMapper, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Steinfort, MBBS, BMedSci, FRACP, PhD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Henky Wibowo, MSc

Role: CONTACT

henky@flexperc.com

4085203500

Facility Contacts

Daniel Steinfort, MBBS

Role: primary

Research@mh.org.au

03) 9342 8530

Other Identifiers

2022-001

Identifier Type: -

Identifier Source: org_study_id