Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06105606
Other study ID # 23-131
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date January 31, 2027

Study information

Verified date January 2024
Source Beth Israel Deaconess Medical Center
Contact Jason Beattie, MD
Phone 617-632-8252
Email jbeattie@bidmc.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


Description:

This research study is a prospective, single-arm, cohort study to evaluate the feasibility of Microwave Ablation (MWA) Probe for the bronchoscopic treatment of malignant lesions causing central airway obstructions (COA). The AveCure prob will be placed in contact with the COA to treat with energy. The U.S. Food and Drug Administration (FDA) has approved this intervention for use throughout the body, but it has not been approved for the specific indication of central airway obstruction. Research study procedures include screening for eligibility, hospitalization for bronchoscopy and MWA, blood tests, survey questionnaires, Computerized Tomography (CT) scan imaging, and pulmonary function tests. Participation in this research study is expected to last about 6 months. It is expected that about 10 people will take part in this research study. MedWaves, Inc is funding this research study by providing the ablation probe and generator.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date January 31, 2027
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients age between 18 and 80 years of age and able to provide informed consent. - Candidate for bronchoscopy under general anesthesia. - 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). Exclusion Criteria: - Patients who are unable to understand the informed consent, including potential risks and benefits of the procedure. - Patients in whom bronchoscopy under general anesthesia is contraindicated. - 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 - Patients with coagulopathy - Patients in other therapeutic lung cancer studies - COVID-19 positive patient at the time of the procedure. - Patients who are pregnant - Patients with purely extrinsic compression of the airway.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AveCure Flexible Microwave Ablation Probe
Consists of a handheld, surgical device which delivers microwave energy from its microwave antenna. The flexible probe has a 3cm active microwave field that radiates from the tip.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center MedWaves, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility Failure Rate (FFR) Feasibility of the AveCure microwave technology to ablate a target malignant central and lobar airway lesions causing > 50% obstruction, defined as at least 9/10 of the planned ablations (90%) successfully performed bronchoscopically according to the study protocol 6 months
Secondary 6-month airway patency rate 6-month airway patency rate defined as the proportion of participants achieve airway patency. Airway patency will be calculated as the minimal airway luminal area at the CAO as a percentage of the average of the distal and proximal airway luminal areas. 6 months
Secondary Grade 3-5 Treatment-related Toxicity Rate All grade 3-5 adverse events (AE) with attribution of possibly, probably or definitely related to neoadjuvant treatment based on CTCAEv5 are counted. Rate is the proportion of treated participants with at least one post-baseline safety assessment experiencing at least one of these adverse events during the time of observation. Adverse events evaluated 1, 3 and 6 month after procedure.
Secondary Airway Obstruction (AO) Rate AO Rate defined as percentage of airway obstruction assessed at bronchoscopy and on CT scan after the study procedure measured through the Myer-Cotton grading system and percentage change in luminal cross sectional area. Central airway obstruction (CAO) is defined as occlusion of more than 50% of the trachea, mainstem bronchi, bronchus intermedius, or a lobar bronchus. CT scan at 1, 3, 6 and 12 months after procedure
Secondary Change in Subjective Perception of Dyspnea subjective perception of dyspnea as measured by the modified Medical Research Council dyspnea scale (mMRC) Assessed 1, 3, 6 and 12 months after procedure.
Secondary Number and type of additional tools that are used during bronchoscopy. Index procedure only (at ablation).
Secondary Procedural Bleeding bleeding assessed by the Nashville scale Index procedure only (at ablation).
Secondary Change in peak flow measurement Peak flow measurement using a standard peak flow meter will also be performed by research staff. Baseline to 30 days +/- 7 days post ablation
Secondary 6-month Overall Survival (OS) 6-month OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive. 6 months
Secondary 6-month mechanical ventilation-free survival 6-month mechanical ventilation-free survival is a probability estimated using the Kaplan Meier method; PFS is defined as the duration of time from study entry to documented mechanical ventilation. 6 months
Secondary Histologic characteristics of tissue ablated with the AveCure microwave technology device. Index procedure only (at ablation).
Secondary MW number of energy applications Index procedure only (at ablation)
Secondary MW time of application seconds Index procedure only (at ablation)
Secondary Total time of MW ablation seconds Index procedure only (at ablation)
Secondary Total energy delivered during MW ablation mW Index procedure only (at ablation)
Secondary Temperature during ablation degrees Celsius Index procedure only (at ablation)
Secondary Length of ablation procedure minutes Index procedure only (at ablation)
Secondary Change in Quality of Life (QoL) as measured by Saint George Respiratory Questionnaire (SGRQ) ssessed 1, 3, 6 and 12 months after procedure.
Secondary Procedural bleeding estimated blood loss (mL) Index procedure only (at ablation)
Secondary Change in Quality of Life (QoL) measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) Assessed 1, 3, 6 and 12 months after procedure.
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04506346 - Risk Prediction of Difficult Tracheal Intubation in OSAHS Patient
Completed NCT02106143 - RejuvenAirâ„¢ System Lobectomy Safety and Histology Study N/A
Completed NCT03274791 - Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD N/A
Completed NCT01765530 - Efficacy Study of a Novel Device to Clean the Endotracheal Tube N/A
Completed NCT01721486 - Acetaminophen's Efficacy For Post-operative Pain Phase 4
Completed NCT03656315 - Scoring System to Predict Depth of Cricothyroid Membrane N/A
Recruiting NCT05880836 - In Line Aerosol Nebulization With High Flow N/A
Recruiting NCT05573919 - VivAer: A Correlation Between Symptom Scores and Objective Findings N/A
Completed NCT02403934 - Jaw Elevation Device in Deep Sedation Study N/A
Recruiting NCT00452062 - Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults Phase 2
Completed NCT02563210 - Airway Resistance Measurement in Children 3 to 6 Years of Age N/A
Completed NCT03488849 - SureCRIC Standardized Patient Study
Completed NCT03752593 - The Incidence of Difficult Intubation in Obese Versus Non-obese Patients
Recruiting NCT05974488 - The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE N/A
Not yet recruiting NCT02975791 - Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane N/A
Completed NCT00788788 - Heliox in Experimental Upper Airway Obstruction Phase 1/Phase 2
Not yet recruiting NCT06128811 - Dental Isolation Systems Among Pediatric Patients With Different Airway Patency N/A
Completed NCT05550220 - A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients N/A
Completed NCT03165461 - Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
Recruiting NCT03969147 - Investigation of a Novel Oropharyngeal Airway: The ManMaxAirway N/A