Recruiting

Avecure

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05281237

Conditions

Stage I - II Primary Lung Cancer

Stage I Lung Cancer

Stage II Lung Cancer

Lung Cancer Stage I

Lung Cancer Stage II

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

AveCure 16 Gauge Flexible Microwave Ablation Probe

Study Details

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 - II Primary Lung Cancer

Stage I Lung Cancer

Stage II Lung Cancer

Lung Cancer Stage I

Lung Cancer Stage II

Study ID

NCT05281237

Start date

Jun 1, 2022

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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

Primary outcome measure

  • Rate of Planned Ablations. [ Time Frame: Day 1 ]
  • Pathological changes in the tumor tissue. [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Jason Beattie, MD

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

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator:

Beattie Jason, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-04-08.