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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 30 days +/- 7 days post ablation

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 30 days +/- 7 days post ablation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 30 days +/- 7 days post ablation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 30 days +/- 7 days post ablation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility Failure Rate (FFR)

Secondary outcome measures

6-month Overall Survival (OS)

6-month airway patency rate

6-month mechanical ventilation-free survival

+16 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

MedWaves, IncUNKNOWN

1 Previous Clinical Trials

10 Total Patients Enrolled

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,262 Total Patients Enrolled

Jason Beattie, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center

1 Previous Clinical Trials

10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my profile suitable for participation in this research?

"The prerequisites for this trial necessitate that participants have a blocked airway and are between 18 to 80 years of age. There is space enough for 10 individuals in the study."

Answered by AI

Are geriatric individuals being taken into consideration for this research trial?

"The eligibility criteria for this clinical trial states that suitable participants must be between 18 and 80 years old. For those aged under 18 or over 65, there are 3 studies and 15 trials respectively available to them."

Answered by AI

Are there any openings in this clinical trial for participants?

"The information hosted on clinicaltrials.gov shows that this trial, which was initiated in December 1st 2023 and last updated October 26th 2023, is no longer recruiting participants at the present time. However, there are other medical studies actively enrolling patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions

Jason A Beattie 2024. "Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105606.