A Post-market Feasibility Study Evaluating Location Accuracy Using the superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology in Subjects Undergoing Lung Lesion Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Confirm the Location Accuracy of the Local Registration Feature
研究概览
简要总结
The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
详细描述
The primary objective of this post-market feasibility study is to confirm the location accuracy of the local registration feature of the superDimension™ Navigation System Version 7.2 in subjects undergoing lung lesion biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 presents with lung lesion(s) 10 mm or greater in diameter amenable to evaluation by ENB at the time of evaluation
- •Lesion is intended to be biopsied by the participating investigator
- •Subject is willing and able to provide informed consent to participate in the study
- •Subject is a candidate for an elective ENB procedure
- •Subject is over the age of 18
排除标准
- •Central lesions that are visible endobronchially or could be reached by a flexible bronchoscope or endobronchial ultrasound (EBUS) without the utilization of ENB
- •Lesions within 10 mm of the diaphragm
- •The subject is unable or unwilling to comply with study follow-up schedule
- •The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- •Female subjects who are pregnant or nursing as determined by standard site practices
结局指标
主要结局
Confirm the Location Accuracy of the Local Registration Feature
时间窗: day of procedure
The Primary Endpoint is the measured ability of the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology to place the center of the virtual navigation target (green ball) on the intended target lesion as confirmed by cone-beam computed tomography (CBCT). The primary endpoint was evaluated in technically successful cases (those with local registration complete) and calculated as the percentage of cases in which the virtual target was correctly placed to overlap the target lesion, as confirmed by CBCT. The percent overlap was calculated in three dimensions (X, Y, and Z coordinates). Any case with more than 0% overlap was considered a primary endpoint success.
次要结局
- Total Procedure Time(day of procedure)
- ENB Procedure Time(day of procedure)
- Total Fluoroscopy Time(day of procedure)
- Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable)(day of procedure)
- Percentage of Cases in Which the Intended Lesion is Correctly Identified(day of procedure)
- Number of Cases That Are Not Technically Successful (Local Registration Not Complete)(day of procedure)
- Investigator Confirmation That the Catheter is in an "Adequate Periprocedural Location" Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology.(day of procedure)
- Number of Cases That Are Technically Successful (Successful Completion of Local Registration)(day of procedure)
- Biopsy Tools Used(day of procedure)
- Number of Tool Pases(day of procedure)
- Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample(Based on ROSE results of the ENB-aided biopsy sample collected day of procedure)
- Adequacy of the ENB-aided Tissue Sample(Based on final pathology results of the ENB-aided biopsy sample collected day of procedure)
- Final Pathology Results of the ENB-aided Tissue Sample(Based on final pathology results of the ENB-aided biopsy sample collected day of procedure)
- Tool Order(day of procedure)
- Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample(Based on final pathology results of the ENB-aided sample collected day of procedure)
- Relational Accuracy in Cases in Which the Intended Lesion is Targeted(day of procedure)