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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

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
Trial website
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
henky@flexperc.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06158971