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Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 45 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-03-12

Primary completion: 2025-01-31

Study completion finish: 2025-01-31

Study type

OTHER

Phase

Trial ID

NCT06158971

Intervention or treatment

DEVICE: Flexible Bronchoscopic Microwave Ablation

Conditions

• Lung Neoplasm

Condition: Lung Neoplasm
DEVICE: Flexible Bronchoscopic Microwave Ablation
Melbourne, Victoria, Australia
Sponsor: phenoMapper, LLC

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Melbourne Hospital

Research sites nearby

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Royal Melbourne Hospital
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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)

Frequently Asked Questions

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References

Clinical Trials Gov: Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation