Microwave Ablation for Airway Blockage

Overseen By Jason Beattie, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Pacemaker, Coagulopathy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 week

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with cancer-related airway blockages. The AveCure Microwave Ablation Probe uses microwave energy to remove these blockages. The trial aims to determine the safety and effectiveness of this method. Suitable candidates have a cancer-related blockage in their main airways, such as the trachea, confirmed by imaging tests, and require a bronchoscopy. Researchers will monitor participants before and after the procedure to track progress.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research and potentially benefit from a novel treatment approach.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that the AveCure Flexible Microwave Ablation Probe is safe for treating malignant central airway obstruction?

Research shows that AveCure Microwave Ablation technology is being tested to treat airway blockages caused by cancer. Previous studies have used this method for similar conditions, suggesting it could be safe for patients. Reports from these studies indicate it is generally well-tolerated, with most people not experiencing serious side effects.

In one small study, patients underwent microwave ablation through a bronchoscope (a thin tube with a light and lens) to manage airway blockages. The results suggested that patients handled the procedure without major problems. This technology resembles other FDA-approved microwave ablation devices used in different treatments, indicating potential safety.

While more data is needed to fully confirm safety, existing evidence is promising. Participants in these studies have mostly reported mild side effects, if any, which is encouraging for those considering joining trials with this device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for airway blockages, which often involve surgical removal or stenting, AveCure Microwave Ablation Technology uses targeted microwave energy to clear blockages. This method precisely destroys the obstructive tissue while minimizing damage to surrounding healthy tissue. Researchers are excited because this approach could offer a less invasive, more precise option with potentially faster recovery times and fewer complications compared to conventional techniques.

What evidence suggests that the AveCure Microwave Ablation Technology is effective for treating malignant central airway obstruction?

Research has shown that microwave ablation (MWA) can help treat blockages in the main airways caused by cancer. Early results from a small study indicated that this method, when used with flexible bronchoscopy (a tube with a light and camera to examine the airways), can destroy tumors and keep the airways open. Participants in this trial will undergo the AveCure Microwave Ablation procedure, which uses microwave energy to heat and remove the blocked tissue. This new approach offers hope for patients with this condition. Initial studies suggest it can clear airway blockages and improve breathing. ^{1 2 3 5 6}

Who Is on the Research Team?

Jason Beattie, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with malignant central airway obstruction, confirmed by imaging, who are candidates for bronchoscopy under general anesthesia. It's not suitable for those unable to consent, at high risk from anesthesia, with coagulopathy or electronic implants like pacemakers, COVID-19 positive patients, pregnant women, those with only external airway compression or enrolled in other lung cancer studies.

Inclusion Criteria

I have a blockage in my airways due to cancer, confirmed by scans, and need a procedure to clear it.

I am eligible for a lung examination procedure under complete sedation.

Exclusion Criteria

My breathing issue is due to something pressing on my airway from the outside.

I cannot undergo bronchoscopy with general anesthesia due to health risks.

Patients who are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline assessments including blood tests, survey questionnaires, CT scan imaging, and pulmonary function tests

1 week

1 visit (in-person)

Treatment

Hospital admission for bronchoscopy under general anesthesia and microwave ablation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment at 1, 3, and 6 months post-procedure

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AveCure Microwave Ablation Technology

Trial Overview The study tests the AveCure Microwave Ablation Probe's ability to treat malignant blockages in the lungs' main airways using a flexible probe that delivers microwave energy during a bronchoscopic procedure. The focus is on assessing how practical and safe this technology is.

How Is the Trial Designed?

Group I: AvuCure Microwave Ablation Experimental Treatment 1 Intervention

Participants will undergo study procedures as follows: * Baseline assessments * Hospital admission for bronchoscopy under general anesthesia and microwave ablation via standard of care. * Participants will be followed at 1, 3, and 6 months post-procedure.

AveCure Microwave Ablation Technology is already approved in European Union, United States for the following indications:

Approved in European Union as AveCure Microwave Ablation System for:

• Soft tissue tumors
• Bone tumors

Approved in United States as AveCure BT Microwave Ablation System for:

• Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body
• Coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for other treatments

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

MedWaves, Inc

Collaborator

Trials

2

Recruited

20+

Published Research Related to This Trial

The aerosol containment mask (ACM) effectively prevented leakage of 0.3 μm particles during both rigid and flexible endoscopic procedures, ensuring protection against patient-generated aerosols for healthcare workers.

Patient comfort was generally high, with 73% finding the ACM comfortable without suction and 86% with suction, while surgeons reported successful visualization of necessary anatomy in 98% of procedures, indicating the ACM's practicality in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 in the Clinic: Trial of an Aerosol Containment Mask for Endoscopic Clinic Procedures. Ference, EH., Kim, W., Oghalai, JS., et al.[2023]

The aerosol containment mask (ACM) was designed and tested on 10 healthy volunteers, showing that it can effectively accommodate endoscopic procedures while providing protection against aerosol particles, particularly during sneezing and coughing.

The study found that while there were fluctuations in aerosol particle counts, the ACM generally prevented significant leakage of aerosols, suggesting it could help protect healthcare workers from airborne contagions during otolaryngologic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 in the Clinic: Human Testing of an Aerosol Containment Mask for Endoscopic Clinic Procedures. Ference, EH., Kim, W., Oghalai, JS., et al.[2022]

A study involving 40 patients with chronic nasal congestion showed that using a device that combines nasal acoustic vibration and oscillating expiratory pressure significantly improved nasal airflow and symptoms over 5 weeks, with no adverse effects reported.

Patients experienced substantial reductions in nasal congestion scores, with 80% expressing willingness to use the device again, indicating both safety and promising efficacy for this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel device combining acoustic vibration with oscillating expiratory pressure for the treatment of nasal congestion. Soler, ZM., Nguyen, SA., Salvador, C., et al.[2021]

The use of a novel three-dimensional visualization ablation planning system (3D-VAPS) in microwave ablation (MWA) for stage I non-small cell lung cancer (NSCLC) resulted in a 100% technical success rate and a 97.35% complete ablation rate three months post-procedure, indicating high efficacy.

The study reported no deaths during or within 30 days after the MWA procedure, and while complications such as pneumothorax and intrapulmonary hemorrhage occurred, the overall safety profile was deemed acceptable, suggesting that 3D-VAPS can help optimize the procedure and reduce risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and feasibility of three-dimensional visualization planning system for CT-guided microwave ablation of stage I NSCLC (diameter ≤2.5 cm): A pilot study. Hu, Y., Xue, G., Liang, X., et al.[2023]

In a study of 25 patients with painful pelvic bone metastasis, microwave ablation combined with cementoplasty under O-arm navigation significantly reduced pain levels, with average VAS scores dropping from 7.0 before the procedure to 1.2 three months post-treatment.

The procedure was safe, with no major complications reported, and it improved patients' quality of life and functional scores, indicating its efficacy in managing symptoms associated with bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

O-arm-guided percutaneous microwave ablation and cementoplasty for the treatment of pelvic acetabulum bone metastasis. Zuo, D., Sun, M., Mu, H., et al.[2022]

Microwave ablation (MWA) has been shown to significantly reduce postoperative pain in patients with metastatic spinal tumors, with effective pain relief lasting up to 6 months in select cases, based on a review of 156 patients across 8 studies.

Local tumor control was achieved in over 80% of patients, indicating that MWA may have a potential curative role when used in combination with other treatments, despite some complications occurring in a small percentage of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave Ablation as a Treatment for Spinal Metastatic Tumors: A Systematic Review. Sagoo, NS., Haider, AS., Rowe, SE., et al.[2021]

A pilot study with 15 healthy volunteers demonstrated that an innovative mask prototype significantly reduced the emission of small aerosol particles (0.3 μm) during activities like breathing, speaking, and singing compared to no mask, indicating its efficacy in minimizing aerosol transmission risk.

The mask's design, which includes a physical barrier, a negative pressure environment, and dual filtration, provides effective protection against aerosol-generating procedures, making it a promising tool for reducing COVID-19 transmission risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative dual-function protective scope mask and filtration system for aerosol generating ENT scope procedures. Chew, HS., Tan, M., Sanchalika, A., et al.[2023]

Microwave ablation using three antennas was successfully performed on 10 patients with unresectable liver tumors, showing effective tumor destruction with clear coagulation necrosis observed in histological examinations.

The mean ablation zone was larger than the tumor size, indicating that the technique can effectively target and destroy liver tumors, even near large blood vessels, suggesting its potential for safe application in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative triple antenna hepatic microwave ablation. Simon, CJ., Dupuy, DE., Iannitti, DA., et al.[2022]

In a pilot study involving 8 patients, endobronchial microwave ablation (MWA) successfully recanalized the airway in all cases without any complications, demonstrating its safety and efficacy for managing malignant central airway obstruction (CAO).

The technique effectively destroys tumors while preserving the airway structure, utilizing the 'oven effect' to safely devitalize tissue without harming surrounding areas, making it a promising option for patients with CAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave Ablation for Malignant Central Airway Obstruction: A Pilot Study. Senitko, M., Oberg, CL., Abraham, GE., et al.[2022]

In a study of 29 patients with mild to moderate obstructive sleep apnea, temperature-controlled radiofrequency ablation significantly reduced the mean respiratory disturbance index from 19.0 to 9.8 events per hour, indicating improved breathing during sleep.

Approximately 65.5% of patients were cured of their obstructive sleep apnea after treatment, and snoring levels decreased significantly, suggesting that this intervention can effectively alleviate symptoms in selected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation for the treatment of mild to moderate obstructive sleep apnea. Blumen, MB., Dahan, S., Fleury, B., et al.[2004]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06105606

Feasibility of the AveCure Microwave Ablation Technology ... This research study is a prospective, single-arm, cohort study to evaluate the feasibility of Microwave Ablation (MWA) Probe for the bronchoscopic treatment of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9393822/

Microwave Ablation for Malignant Central Airway Obstruction We present a pilot study utilizing endobronchial MWA via flexible bronchoscopy as a novel modality for the management of malignant CAO.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-09940

AveCure Flexible Microwave Ablation Probe for the ... This clinical trial evaluates the feasibility of the AveCure flexible microwave ablation probe for treating patients with malignant central airway obstruction.

4. alicantobidmc.org alicantobidmc.org/resources/feasibility-avecure-microwave-ablation-technology-bronchoscopic-treatment-malignant

Feasibility of the AveCure Microwave Ablation Technology ... This research study is a prospective, single-arm, cohort study to evaluate the feasibility of Microwave Ablation (MWA) Probe for the bronchoscopic treatment of ...

5. scholarshare.temple.edu scholarshare.temple.edu/bitstreams/6c0dbfc5-5592-4380-97a6-dab7c80629ba/download

Microwave Ablation for Malignant Central Airway Obstruction Discussion:Endobronchial MWA is a novel tech- nique for tumor destruction while maintaining an airway axis. The oven effect and air gap around a tumor allow for.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K192406.pdf

K192406/S002 Trade/Devic - accessdata.fda.gov The MedWaves' AveCure BT Microwave Ablation System is comprised of a microwave (915MHz ±13MHz) generator-controller, two antenna sizes mounted ...