Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

Not Applicable

Recruiting

• Conditions: Lung Neoplasm
• Interventions: Device: Flexible Bronchoscopic Microwave Ablation

• Registration Number: NCT06158971
• Lead Sponsor: phenoMapper, LLC

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.

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Study Start: 2024-03-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flexible Microwave Ablation	Flexible Bronchoscopic 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia