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Procedure

Microwave Ablation for Airway Blockage

N/A

Recruiting

Led By Jason Beattie, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of central airway obstruction (trachea, right main stem bronchus, left main stem bronchus), as evidenced by CT or CT/PET imaging confirmed or suspected to be due to malignant etiology, for which the bronchoscopist has deemed that endoscopic ablation/debridement is indicated (i.e. endobronchial tumors, mixed endobronchial/extrinsic compression lesions)

Patients age between 18 and 80 years of age and able to provide informed consent

Must not have

Patients with purely extrinsic compression of the airway

Patients in whom bronchoscopy under general anesthesia is contraindicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ct scan at 1, 3, 6 and 12 months after procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a microwave probe to treat malignant airway blockages.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, risks associated with general anesthesia and bronchoscopy such as infection or bleeding, possible damage to surrounding tissues due to microwave energy exposure and complications related to heat generation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 80 years old and can give my consent.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am currently COVID-19 positive.

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I have a blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ct scan at 1, 3, 6 and 12 months after procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ct scan at 1, 3, 6 and 12 months after procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and ct scan at 1, 3, 6 and 12 months after procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility Failure Rate (FFR)

Secondary study objectives

6-month Overall Survival (OS)

6-month airway patency rate

6-month mechanical ventilation-free survival

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AvuCure Microwave AblationExperimental Treatment1 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.

0 / 7Eligibility criteria met