Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Feasibility Failure Rate (FFR)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
AvuCure Microwave Ablation
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.
干预措施: AveCure Flexible Microwave Ablation Probe (Device)
结局指标
主要结局
Feasibility Failure Rate (FFR)
时间窗: 6 months
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
次要结局
- 6-month airway patency rate(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))
- Length of ablation procedure(Index procedure only (at ablation))
- Grade 3-5 Treatment-related Toxicity Rate(Adverse events evaluated 1, 3 and 6 month after procedure.)
- Airway Obstruction (AO) Rate(CT scan at 1, 3, 6 and 12 months after procedure)
- Procedural Bleeding(Index procedure only (at ablation).)
- 6-month mechanical ventilation-free survival(6 months)
- Total energy delivered during MW ablation(Index procedure only (at ablation))
- MW time of application(Index procedure only (at ablation))
- Change in Subjective Perception of Dyspnea(Assessed 1, 3, 6 and 12 months after procedure.)
- Change in peak flow measurement(Baseline to 30 days +/- 7 days post ablation)
- Total time of MW ablation(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.)
- Number and type of additional tools that are used during bronchoscopy.(Index procedure only (at ablation).)
- 6-month Overall Survival (OS)(6 months)
- Temperature during ablation(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(Index procedure only (at ablation))
研究者
Jason A Beattie
Principal Investigator
Beth Israel Deaconess Medical Center