ACTRN12624001045505尚未招募Unknown
The REMOVE Study - Endobronchial Thermal Liquid Ablation - Lung Cancer (ETLA-LC) for the Treatment of Pulmonary Cancer Lesions - A First in Human Treat and Resect Study (CSP-21123) for patients with non-small cell lung cancer.
Morair Medtech, Pty. Ltd0 个研究点目标入组 10 人开始时间: 2024年8月28日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •General Inclusion Criteria
- •-Age greater than or equal to 18 years old
- •-Non-small cell lung cancer tumor(s) suitable for lobectomy
- •-Suitable candidate for lobectomy as per standard of care
- •-Pathologically confirmed malignancy obtained via bronchoscopic biopsy with adequate yield to perform definitive diagnosis
- •-Cognitively able to provide written informed consent
- •Radiographic Inclusion Criteria
- •-Longest axis of tumor less than 3cm per HRCT analysis by QCT Core lab
- •-Tumor is identified in the periphery of lung (outer 2/3rd) by radiologic reviewer in addition to site radiologist.
- •-Tumor resides in eligible segment(s) per HRCT analysis by QCT Core lab, with target treatment location not adjacent to lobar fissure planned for resection, and assessed by surgeon
- •-Tumor resides within two or fewer eligible segments per HRCT analysis by QCT Core lab with treatment at the segmental or subsegmental level.
排除标准
- •General Exclusion Criteria
- •-Post-bronchodilator FEV1 of less than 40% predicted or recent COPD exacerbation requiring treatment within 1 year of screening
- •-DLCO less than 40% predicted
- •-Supplemental oxygen at rest or during exercise
- •-Hospitalization for cardiac event within 6 months of screening
- •-Liver enzymes (AST, ALT, ALP) or total bilirubin more than 1.5 times upper limit of normal (ULN)
- •-Serum creatinine greater than 2 mg/dL
- •-Receiving immunosuppressive medication or prednisone greater than 15 mg/day (or equivalent)
- •-Receiving adjunct chemotherapy
- •-Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
- •-History of severe hemoptysis or persistent hemoptysis.
- •-Disorder of coagulation or receiving anticoagulant and/or antiplatelet medication.
- •Note: Antiplatelet/anticoagulant medication is permitted provided that the medication can be held per physician discretion based on specific agent prior to the procedure and through to planned surgical resection.
- •-Unablated tumor tissue is required from the resection to inform patient’s ongoing cancer treatment.
- •-Any condition that in the opinion of the investigator may interfere with the safety of the patient or evaluation of the study objectives.
- •-Any condition that would interfere with completion of the study including study assessments and procedures.
- •-Any tumor characteristic that in the opinion of the investigator may interfere with the safety of the patient or evaluation of the study objectives.
- •-Currently enrolled in another trial studying an experimental treatment that in the opinion of the investigator may impact this study.
- •Radiographic Exclusion Criteria
- •-Tumor invading beyond pleura into chest wall
- •NOTE: HRCT analysis by QCT Core Lab
- •Tumor invading beyond pleura into check wall assessed by Radiologic Eligibility Reviewer in addition to site radiology
- •Pre-procedural Exclusion Criteria
- •-Active respiratory infection or recent respiratory infection with resolution less than 4 weeks prior to screening or procedure.
研究者
相似试验
招募中
不适用
Bronchoscopic Vapour Therapy for Emphysema (unilateral treatment)EmphysemaRespiratory - Chronic obstructive pulmonary diseaseACTRN12609000822280ptake Medical Corp.40
招募中
不适用
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of EmphysemaEmphysemaNCT06655428Morair Medtech, LLC30
尚未招募
不适用
A study to show the efficiency of internal radiotherapy of respiratory tract for releasing airway obstructioCTRI/2019/03/018346All India Institute of medical sciences
招募中
不适用
The REDUCE Study – Safety of the Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Severe Emphysema with hyperinflation – A First in Human Study (CSP-11121EmphysemaACTRN12622001327774Morair Medtech LLC30
招募中
不适用
Effect of warm endotracheal tube insertion on post operation sore throat and hoarsenessAcute pharyngitisCondition 1: Sore throat. Condition 2: Hoarseness.DysphoniaIRCT201708294365N22Vice chancellor for Research and Technology of Mazandaran University of Medical Sciences124