A Pilot Prospective Study Evaluating the SPiN Drive(TM)Electromagnetic Tip Tracked Devices Used in Diagnostic Bronchoscopy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm.
研究概览
简要总结
The objective of the prospective, multi-center study is to evaluate the ease of use and effectiveness of the SPiN Drive Electromagnetic (EM) Tip Tracked Steerable Devices as a method of sampling subsegmental, less than 3.0 cm, lung lesions through the airway, and beyond the bronchus. Measures of diagnostic yield will be compared to the diagnostic yield of similar published historical controls using conventional bronchoscopy.
详细描述
Always On EM Tip Tracked Steerable catheters and biopsy devices used with the Veran Medical Technologies system are Food and Durg Administration 510K approved for use in diagnostic pulmonary procedures to locate and sample subsegmental peripheral, less than 3.0 centimeter lung lesions or solitary pulmonary nodules(SPN).
Up to 20 subjects with radiographically confirmed peripheral lung lesions will be asked to participate in the study and proceed with informed consent. An interim analysis of the data will be conducted to determine the need to include an additional 10 patients to achieve statistically significant results at the ninety five percent confidence interval.
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
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject provides informed consent
- •Subject is older than 50 years of age with 50% of patients at least 65 years of age
- •Patient has a minimum of 20 pack years
- •Subject scheduled to undergo conventional bronchoscopy as part of their standard medical care
- •Subject has radiographically confirmed sub-segmental peripheral < 3.0 cm lung lesions
- •A negative pregnancy test in women of child-bearing potential
- •Subject is willing and able to return for all required follow-up
- •Subject is mentally capable of following study directions
排除标准
- •Subject has pacemaker, implantable cardioverter, and/or defibrillator
- •Subject has any disease or condition that interferes with safe completion of initial or follow-up assessments
- •Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy prior to their enrollment in this study
- •Concurrent participation in another study involving investigational drugs or investigational medical devices
- •Inability to read and understand the necessary study documents
研究组 & 干预措施
Patients recommended for a lung biopsy.
Patients with a positive diagnosis of a peripheral, less than 3.0 centimeter lung lesion, recommended for bronchoscopic biopsy are eligible to be consented into the study.
干预措施: Lung biopsy using Always On EM Tip Tracked Device (Procedure)
结局指标
主要结局
Diagnostic yield of a subsegmental pulmonary lesion of less than 3.0 cm.
时间窗: Within 1 week
Biopsy samples will be sent to the lab for analysis of the presence, absence, or identification of an occult particulate taken from the patient's lung. Patients with a negative biopsy result will be followed if recommended for another intervention and if recommended to watchful waiting. Follow up outcomes will be included in the outcome measures.
次要结局
未报告次要终点