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Low accrual
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AvuCure Microwave Ablation | Experimental | Participants will undergo study procedures as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AveCure Flexible Microwave Ablation Probe | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Grade 3-5 Treatment-related Toxicity Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Beattie, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
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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. |
| 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 |
| 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. |
| Number and type of additional tools that are used during bronchoscopy. | Index procedure only (at ablation). |
| Procedural Bleeding | bleeding assessed by the Nashville scale | Index procedure only (at ablation). |
| 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 |
| 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 |
| 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 |
| Histologic characteristics of tissue ablated with the AveCure microwave technology device. | Index procedure only (at ablation). |
| MW number of energy applications | Index procedure only (at ablation) |
| MW time of application | seconds | Index procedure only (at ablation) |
| Total time of MW ablation | seconds | Index procedure only (at ablation) |
| Total energy delivered during MW ablation | mW | Index procedure only (at ablation) |
| Temperature during ablation | degrees Celsius | Index procedure only (at ablation) |
| Length of ablation procedure | minutes | Index procedure only (at ablation) |
| Change in Quality of Life (QoL) as measured by Saint George Respiratory Questionnaire (SGRQ) | ssessed 1, 3, 6 and 12 months after procedure. |
| Procedural bleeding | estimated blood loss (mL) | Index procedure only (at ablation) |
| 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. |
| ID | Term |
|---|---|
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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