Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

NCT06158971 | Recruiting DMC FDA Device

• 1 other identifier: 2022-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Neoplasm

Keywords

flexperc medical; microwave; ablation; phenoWave; phenoMapper

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Navigational Success

  Immediately after completion of procedure (day 0)

• Procedural Measures

  Immediately after completion of procedure and navigation to the target (day 0)

Study Arms (1)

Flexible Microwave Ablation

EXPERIMENTAL

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

Interventions

Flexible Bronchoscopic Microwave Ablation DEVICE

The phenoWave flexible microwave ablation system will be used to perform soft tissue ablation in the lungs under image guidance.

Flexible Microwave Ablation

Eligibility Criteria

• Age: 45 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• phenoMapper, LLC: lead
• NIH/NCI - Grant award number: R01CA218357: collaborator

Study Sites (1)

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel Steinfort, MBBS, BMedSci, FRACP, PhD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henky Wibowo, MSc

CONTACT

4085203500; henky@flexperc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: December 6, 2023
• Study Start: March 12, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)