Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

Lung Neoplasm Clinical Trial

Official title:

Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158971
• Other study ID #: 2022-001
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: phenoMapper, LLC
• Contact: Henky Wibowo, MSc
• Phone: 4085203500
• Email: henky[@]flexperc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 77 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasm
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
phenoMapper, LLC	NIH/NCI - Grant award number: R01CA218357

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - AE occurrence	Incidence of complications and occurrence of Adverse Events (AEs)	up to 7 days post ablation
Primary	Safety - AE frequency	Frequency of AEs	up to 7 days post ablation
Primary	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
Primary	Technical Feasibility	Evidence of thermal ablation in portion of the tumor as assessed on histopathology	up to 7 days post ablation
Secondary	Navigational Success	Measured distance of phenoWave device tip relative to the planned position from CT data	Immediately after completion of procedure (day 0)
Secondary	Procedural Measures	Total procedure time and navigation time to position the device	Immediately after completion of procedure and navigation to the target (day 0)