Avecure Flexible Microwave Ablation Probe For Lung Nodules

NCT05281237 | Recruiting DMC FDA Device

• 1 other identifier: 21-412
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

Stage I - II primary lung cancer; Stage I Lung Cancer; Stage II Lung Cancer; Lung Cancer Stage I; Lung Cancer Stage II; Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Rate of Planned Ablations.

  Feasibility of performing the procedure as planned in the enrolled patients. At least 9/10 of the planned ablations (90%) can be performed bronchoscopically according to the established protocol.

  Day 1

• Pathological changes in the tumor tissue.

  Pathological evaluation of the acute thermal effect produced by the AveCUre 16G-FMAP on targeted malignant solitary lung nodules will be described. The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation will be described.

  4 weeks

Secondary Outcomes (2)

• Histological changes in lung tissue outside the zone of predicted ablation.

  4 weeks

• Immune-histochemical changes in the tumor tissue.

  4 weeks

Study Arms (1)

AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES

EXPERIMENTAL

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.

Device: AveCure 16 Gauge Flexible Microwave Ablation Probe

Interventions

AveCure 16 Gauge Flexible Microwave Ablation Probe DEVICE

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

Also known as: Avecure

AVECURE FLEXIBLE MICROWAVE ABLATION PROBE FOR LUNG NODULES

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• MedWaves, Inc: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41137055 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jason Beattie, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Beattie, MD

CONTACT

(617) 632- 8252; jbeattie@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 16, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (1)