Lung NeoplasmNCT06158971
Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
A study testing Flexible Bronchoscopic Microwave Ablation in people with Lung Neoplasm, run by phenoMapper, LLC at 1 site in Australia.
Trial summary
Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung. Read more about this study
- Who is it for?
- Ages 45 to 77 years
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- Flexible Bronchoscopic Microwave Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Mar 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Daniel Steinfort, MBBS, 03) 9342 8530, Research@mh.org.au
About this study
Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.
Read the 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.
- Conditions
- Lung Neoplasm
- Being tested
- Flexible Bronchoscopic Microwave Ablation
- Keywords
- flexperc medical, microwave, ablation, phenoWave, phenoMapper
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Bronchoscopic Microwave AblationDevice
The phenoWave flexible microwave ablation system will be used to perform soft tissue ablation in the lungs under image guidance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Flexible Bronchoscopic Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - AE occurrence
Incidence of complications and occurrence of Adverse Events (AEs)
Measured: up to 7 days post ablation
Safety - AE frequency
Frequency of AEs
Measured: 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
Measured: up to 7 days post ablation
Technical Feasibility
Evidence of thermal ablation in portion of the tumor as assessed on histopathology
Measured: up to 7 days post ablation
Secondary outcomes (2)
Navigational Success
Measured distance of phenoWave device tip relative to the planned position from CT data
Measured: Immediately after completion of procedure (day 0)
Procedural Measures
Total procedure time and navigation time to position the device
Measured: Immediately after completion of procedure and navigation to the target (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start12 Mar 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- phenoMapper, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NIH/NCI - Grant award number: R01CA218357
- Responsible party
- Sponsor
- Investigators
- Daniel Steinfort, MBBS, BMedSci, FRACP, PhD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158971
- Sponsor's protocol ID
- 2022-001
- Status last verified
- Apr 2024
- First submitted
- 5 Jul 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
- ClinicalTrials.gov ID
- NCT06158971
- Acronym / sponsor ID
- 2022-001
- Conditions
- Lung Neoplasm
- Keywords
- flexperc medical, microwave, ablation, phenoWave, phenoMapper
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- phenoMapper, LLCIndustry (pharma, biotech, devices)
- Collaborators
- NIH/NCI - Grant award number: R01CA218357
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexible Microwave Ablation | Experimental | Device: Flexible Bronchoscopic Microwave AblationSoft 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. |
Who may qualify
- Ages
- 45 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- Any contraindication to bronchoscopy, for example:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible Bronchoscopic Microwave AblationThe phenoWave flexible microwave ablation system will be used to perform soft tissue ablation in the lungs under image guidance. | Device | Flexible Microwave Ablation |
Primary outcome
Safety - AE occurrence
Time frame: up to 7 days post ablation
Incidence of complications and occurrence of Adverse Events (AEs)
Safety - AE frequency
Time frame: up to 7 days post ablation
Frequency of AEs
Safety - ablated tissue assessment
Time frame: up to 7 days post ablation
Percentage of ablated tissue within tumor boundary as assessed on gross and/or histologic evaluation
Technical Feasibility
Time frame: up to 7 days post ablation
Evidence of thermal ablation in portion of the tumor as assessed on histopathology
2 secondary outcomes
Navigational Success
Time frame: Immediately after completion of procedure (day 0)
Procedural Measures
Time frame: Immediately after completion of procedure and navigation to the target (day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Lung Neoplasm
RecruitingEarly Phase 1
Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma
Lung Adenocarcinoma, Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Steinfort, MBBS, BMedSci, FRACP, PhD principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible Bronchoscopic Microwave Ablation in people with Lung Neoplasm, run by phenoMapper, LLC at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henky Wibowo, MSc (4085203500, henky@flexperc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - AE occurrence (time frame: up to 7 days post ablation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.