The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 7
- 主要终点
- Ablation Zone Shape
研究概览
简要总结
Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.
详细描述
Primary Endpoint: Dose response as indicated by CT imaging, measurement of maximum diameter and volume.
Secondary Endpoint: Assessment of complete tumor ablation immediately post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or authorized representative has provided informed consent.
- •Subject is ≥18 years of age.
- •At least one pulmonary metastasis ≤ 3.0 cm in maximum diameter resulting from distant primary cancers or at least one recurrence of primary lung cancer ≤ 3.0 cm in maximum diameter.
- •Subject has been confirmed by a thoracic surgeon to be a surgical candidate for resection of the tumor targeted for ablation.
- •Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- •≥1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure.
排除标准
- •Pre-procedure Exclusion Criteria
- •Contraindicated for surgery.
- •Prolonged chest infection, defined as lung consolidation that requires hospitalization and greater than 10 days of antibiotics 30 days prior to surgery.
- •Tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or trachea.
- •Tumor with pleural contact.
- •Tumors located < 3 cm of staple lines or other metal objects.
- •Patients diagnosed with GOLD Stage IV Emphysema.
- •Uncontrollable coagulopathy
- •Patients unable to tolerate discontinued use of anti-coagulants prior to and during the ablation procedure.
- •Subject is pregnant (documented by a positive pregnancy test according to hospital standard practices) or is actively breast-feeding.
- •Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study.
- •The investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
- •Patients with implantable pacemakers and other electronic implants, in accordance with Instructions for Use (IFU).
- •Intraprocedural Exclusion Criteria
- •*Incidental intraprocedural finding that the subject no longer meets the study eligibility criteria.
研究组 & 干预措施
Ablation and Surgical Resection
Ablation of lung tumor; followed by surgical resection of the ablation zone.
干预措施: Ablation (Device)
Ablation and Surgical Resection
Ablation of lung tumor; followed by surgical resection of the ablation zone.
干预措施: Surgical Resection (Procedure)
结局指标
主要结局
Ablation Zone Shape
时间窗: Same day
Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape
Dose Response
时间窗: 1 Day
Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection.
次要结局
- Number of Participants With Complete or Incomplete Tumor Ablation(Same Day)