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Recruiting NCT05281237

Avecure Flexible Microwave Ablation Probe For Lung Nodules

No phase Interventional Stage I - II Primary Lung Cancer Stage I Lung Cancer Stage II Lung Cancer Lung Cancer Stage I

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AveCure 16 Gauge Flexible Microwave Ablation Probe.
Who it may be relevant to
Registry conditions: Stage I - II Primary Lung Cancer, Stage I Lung Cancer, Stage II Lung Cancer, Lung Cancer Stage I. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule

Overview

This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size. This research study involves microwave ablation (MWA)

Detailed description

This will be a single arm, prospective cohort study.

The names of the study intervention involved in this study is:

* Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA) * A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* Participants will receive the study intervention and will be followed for 30 days. * It is expected that about 10 people will take part in this research study.

This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules.

The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.

Interventions

  • Device AveCure 16 Gauge Flexible Microwave Ablation Probe
    Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery

Primary outcome measures

  • Rate of Planned Ablations. [Time frame: Day 1]
  • Pathological changes in the tumor tissue. [Time frame: 4 weeks]
Secondary outcome measures (2)
  • Histological changes in lung tissue outside the zone of predicted ablation. [Time frame: 4 weeks]
  • Immune-histochemical changes in the tumor tissue. [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

  • Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE.
  • Pathological proof of target nodule/tumor type and malignancy with specimen considered adequate per institutional laboratory standards
  • Target nodule/tumor which can be accessed via navigational bronchoscopy and confirmed location with cone beam CT scan intra-operatively
  • Resection/surgical candidate (lobectomy or greater)
  • Participants must be at least 22 years old and able to provide consent

Exclusion criteria

  • Subjects in whom flexible bronchoscopy is contraindicated
  • Target nodule < 1.0 cm
  • Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor
  • Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
  • Pacemaker, implantable cardioverter, or another electronic implantable device
  • Patient cannot tolerate bronchoscopy
  • Patients with coagulopathy
  • Patients in other therapeutic lung cancer studies
  • Subject is pregnant or breastfeeding
  • COVID-19 positive patient at the time of procedure.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Publications

  • Beattie J, Parrish R, Ayasa L, Aranguren P, Uribe-Buritica FL, Lopez MN, Pineda CM, Cheng G, Senitko M, Abdelghani R, Magge A, Avendano CA, Kheir F, Swenson K, Parikh M, Wilson J, VanderLaan PA, Gangadharan S, Majid A. Safety and feasibility of bronchoscopic microwave ablation technology for peripheral lung cancer: a multi-center, prospective, single-arm study protocol. BMC Surg. 2025 Oct 24;25(1) PMID 41137055

Identifiers

NCT: NCT05281237 · 21-412

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗