Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

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

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasm
• Intervention / Treatment: Device: Flexible Bronchoscopic Microwave Ablation

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henky Wibowo, MSc; Phone Number: 4085203500; Email: henky@flexperc.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3050
      • Recruiting
      • Royal Melbourne Hospital
      • Contact: Daniel Steinfort, MBBS; Phone Number: 03) 9342 8530; Email: Research@mh.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Flexible Bronchoscopic Microwave Ablation; The phenoWave flexible microwave ablation system will be used to perform soft tissue ablation in the lungs under image guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - AE occurrence	Incidence of complications and occurrence of Adverse Events (AEs)	up to 7 days post ablation
Safety - AE frequency	Frequency of AEs	up to 7 days post ablation
Safety - ablated tissue assessment	Percentage of ablated tissue within tumor boundary as assessed on gross and/or histologic evaluation	up to 7 days post ablation
Technical Feasibility	Evidence of thermal ablation in portion of the tumor as assessed on histopathology	up to 7 days post ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Navigational Success	Measured distance of phenoWave device tip relative to the planned position from CT data	Immediately after completion of procedure (day 0)
Procedural Measures	Total procedure time and navigation time to position the device	Immediately after completion of procedure and navigation to the target (day 0)

Collaborators and Investigators

• Sponsor: phenoMapper, LLC
• Collaborators: NIH/NCI - Grant award number: R01CA218357
• Investigators: Principal Investigator: Daniel Steinfort, MBBS, BMedSci, FRACP, PhD, Melbourne Health

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ablation; microwave; flexperc medical; phenoWave; phenoMapper
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2022-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes