RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research is being done to evaluate the feasibility of the AveCure Flexible Microwave destruction of tissue (Ablation) Probe for the treatment of malignant central airway obstruction using a thin, tube-like instrument with a light and a lens for viewing and removing tissue (bronchoscopic). The name of the intervention being used in this research study is: AveCure Flexible Microwave Ablation Probe (handheld, surgical device that delivers microwave energy via flexible probe tip)

Official Title

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

Quick Facts

Study Start:2024-03-08
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06105606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients age between 18 and 80 years of age and able to provide informed consent.
  2. * Candidate for bronchoscopy under general anesthesia.
  3. * 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).
  1. * Patients who are unable to understand the informed consent, including potential risks and benefits of the procedure.
  2. * Patients in whom bronchoscopy under general anesthesia is contraindicated.
  3. * Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
  4. * Pacemaker, implantable cardioverter, or another electronic implantable device
  5. * Patients with coagulopathy
  6. * Patients in other therapeutic lung cancer studies
  7. * COVID-19 positive patient at the time of the procedure.
  8. * Patients who are pregnant
  9. * Patients with purely extrinsic compression of the airway.

Contacts and Locations

Study Contact

Jason Beattie, MD
CONTACT
617-632-8252
jbeattie@bidmc.harvard.edu

Principal Investigator

Jason Beattie, MD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Jason Beattie, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-08
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2024-03-08
Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

  • Endoluminal malignant central airway obstruction
  • Central airway obstruction

Additional Relevant MeSH Terms

  • Airway Obstruction
  • Central Airway Obstruction