NCT06249529招募中早期 1 期
Airway Bypass System - Safety and Feasibility Study A SINGLE-CENTER, PROSPECTIVE, SINGLE ARM STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF THE AIRWAY BYPASS SYSTEM
Zoar Engelman1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年1月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The objective of this study is to evaluate its safety and feasibility of the Airway Bypass Stent System in patients with severe emphysema. The study will collect clinical data through 12 months to assess procedural and device safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 50 to 80 years old.
- •High Resolution CT scan indicates severe emphysema.
- •Patient has post- bronchodilator FEV1 less than or equal to 50% of predicted.
- •Total Lung Capacity >100% of predicted.
- •Residual volume ≥225 % of predicted.
- •RV/TLC >0.69
- •Patient has marked dyspnea scoring >2 on mMRC scale of 0-
- •Patient has stopped smoking for a minimum of 8 weeks prior to entering the study, as confirmed by COHb ≤2.5%.
- •Patient read, understood, and signed the Informed Consent form.
- •Subject has completed a pulmonary rehab within the last year and/or performs regular physical activity.
排除标准
- •Patient has clinically significant sputum production.
- •Patient has a change in FEV1 >20% post-bronchodilator.
- •Patient has a history of recurrent clinically significant respiratory infection, defined as with more than 3 hospital stays in the past 12 months.
- •Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure >50mmHg and/or evidenced by echocardiogram.
- •Patient has an inability to walk less than 140 meters (150 yards) or greater than 450 meters in 6 minutes.
- •Patient has evidence of any other disease that may compromise survival such as lung cancer, renal failure, any other investigator identified diseases.
- •Patient has an inability to tolerate bronchoscopy under anesthesia.
- •Any contraindication to bronchoscopy procedure, including but not limited to:
- •Untreatable life-threatening arrhythmias
- •Inability to adequately oxygenate the patient during the procedure
- •Acute respiratory failure with hypercapnia
- •Myocardial infarction within 6 months
- •Previously diagnosed high-grade tracheal obstruction
- •Uncorrectable coagulopathy
- •Patient has clinically significant bronchiectasis.
- •Patient has giant bullae >1/3 lung volume.
- •Patient has had previous LVR surgery, lung transplant or lobectomy, or still has ELVR devices or other device to treat COPD in either lung.
- •Patient has been involved in other clinical studies within 30 days prior to this study.
- •Patient is taking >20mg prednisone (or similar steroid) daily.
- •Patient on antiplatelet agent (e.g., clopidogrel) or anticoagulant therapy (e.g., heparin or coumadin) or has not been weaned off prior to procedure.
- •Patient has any other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes.
- •A known allergy to nitinol.
- •Patient with uncontrolled diabetes as well as overweight patient (BMI >35 kg/m2).
- •Cancer needing chemotherapy in the past two years.
- •Patient with pleural effusion and/or pneumothorax.
- •Patient with a disease history of asthma, cystic fibrosis, interstitial lung disease (ILD), active tuberculosis.
- •Patient with exacerbation of chronic obstructive pulmonary disease (COPD) within the last year which defined as: An acute event with the need of antibiotic treatment or hospitalization.
- •Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mmHg, PaO2 <45 mmHg on room air.
- •Patient with acute ischemic heart disease, with proven pulmonary hypertension (SPAP >45 mmHg) in echocardiography and/or need for double platelet aggregation inhibition.
研究组 & 干预措施
Interventional
Experimental
Patients in the interventional arm will receive implant of one or more airway bypass devices.
干预措施: Airway Bypass (Device)
结局指标
主要结局
Adverse Events
时间窗: 12 Months
including but not limited to device-related blood vessel perforation, pneumothorax, COPD exacerbation, device migration, device removal, rehospitalization.
次要结局
- Dyspnea scale(12 Months)
- CAT(12 Months)
- Implant Success(0 Days)
- FEV1(12 Months)
- Procedural success(1 Days)
- Residual Volume(12 Months)
- 6MWT(12 Months)
研究者
Zoar Engelman
CSO
Deerfield Catalyst
研究点 (1)
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