---
title: Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation
nct_id: NCT06158971
overall_status: UNKNOWN
phase: NA
sponsor: phenoMapper, LLC
study_type: INTERVENTIONAL
primary_condition: Lung Neoplasm
countries: Australia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06158971.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06158971"
ct_last_update_post_date: 2024-04-04
last_seen_at: "2026-05-12T06:34:29.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

**NCT ID:** [NCT06158971](https://clinicaltrials.gov/study/NCT06158971)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** phenoMapper, LLC
- **Collaborators:** NIH/NCI - Grant award number: R01CA218357
- **Conditions:** Lung Neoplasm
- **Start Date:** 2024-03-12
- **Completion Date:** 2025-01-31
- **CT.gov Last Update:** 2024-04-04

## 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

- **Minimum age:** 45 Years
- **Maximum age:** 77 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.

## 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.

## Primary Outcomes

- **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

## 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))_

## Locations (1)

- Royal Melbourne Hospital, Melbourne, Victoria, Australia — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.royal melbourne hospital|melbourne|victoria|australia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06158971.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06158971*  
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