Avecure Flexible Microwave Ablation Probe For Lung Nodules

NCT ID: NCT05281237

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Stage I - II Primary Lung Cancer; Stage I Lung Cancer; Stage II Lung Cancer; Lung Cancer Stage I; Lung Cancer Stage II; Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES

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

• Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm.
• CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure.
• Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology.

Group Type: EXPERIMENTAL

AveCure 16 Gauge Flexible Microwave Ablation Probe

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Avecure

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedWaves, Inc

UNKNOWN

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jason A Beattie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Beattie, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jason Beattie, MD

Role: CONTACT

jbeattie@bidmc.harvard.edu

(617) 632- 8252

References

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):497. doi: 10.1186/s12893-025-03230-y.

Reference Type: DERIVED

PMID: 41137055 (View on PubMed)

Other Identifiers

21-412

Identifier Type: -

Identifier Source: org_study_id