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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06158971




Registration number
NCT06158971
Ethics application status
Date submitted
5/07/2023
Date registered
6/12/2023
Date last updated
4/04/2024

Titles & IDs
Public title
Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
Scientific title
Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
Secondary ID [1] 0 0
2022-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Flexible Bronchoscopic Microwave Ablation

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.


Treatment: Devices: Flexible Bronchoscopic Microwave Ablation
The phenoWave flexible microwave ablation system will be used to perform soft tissue ablation in the lungs under image guidance.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety - AE occurrence
Timepoint [1] 0 0
up to 7 days post ablation
Primary outcome [2] 0 0
Safety - AE frequency
Timepoint [2] 0 0
up to 7 days post ablation
Primary outcome [3] 0 0
Safety - ablated tissue assessment
Timepoint [3] 0 0
up to 7 days post ablation
Primary outcome [4] 0 0
Technical Feasibility
Timepoint [4] 0 0
up to 7 days post ablation
Secondary outcome [1] 0 0
Navigational Success
Timepoint [1] 0 0
Immediately after completion of procedure (day 0)
Secondary outcome [2] 0 0
Procedural Measures
Timepoint [2] 0 0
Immediately after completion of procedure and navigation to the target (day 0)

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
77 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
phenoMapper, LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NIH/NCI - Grant award number: R01CA218357
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.
Trial website
https://clinicaltrials.gov/study/NCT06158971
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Steinfort, MBBS, BMedSci, FRACP, PhD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Henky Wibowo, MSc
Address 0 0
Country 0 0
Phone 0 0
4085203500
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06158971