Clinical trial NCT06158971: Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
Official title: Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Neoplasm
Keywords: flexperc medical
microwave
ablation
phenoWave
phenoMapper
Lead sponsor: phenoMapper, LLC
Sponsor class: INDUSTRY
Collaborators: name: NIH/NCI - Grant award number: R01CA218357
First posted: 2023-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 45
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Safety - AE occurrence
timeFrame: up to 7 days post ablation
measure: Safety - AE frequency
timeFrame: up to 7 days post ablation
measure: Safety - ablated tissue assessment
timeFrame: up to 7 days post ablation
measure: Technical Feasibility
timeFrame: up to 7 days post ablation
Secondary outcomes:
measure: Navigational Success
timeFrame: Immediately after completion of procedure (day 0)
measure: Procedural Measures
timeFrame: Immediately after completion of procedure and navigation to the target (day 0)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Daniel Steinfort, MBBS, BMedSci, FRACP, PhD
role: PRINCIPAL_INVESTIGATOR
References: