Identification of Features Associated With Dysplasia Using the NvisionVLE® Imaging System Pilot Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 10
- 主要终点
- Performance of manually identified VLE features in predicting biopsy defined dysplasia
研究概览
简要总结
The NvisionVLE® Dysplasia Detection Pilot Study is a prospective, non-randomized trial for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).
详细描述
The NvisionVLE® Dysplasia Detection Pilot Study is a collection of data for research. Participation is completely voluntary and does not affect the patient's medical care that chooses not to participate. The purpose of this Study is to determine the performance of the NvisionVLE® Imaging System in determining features of dysplastic Barrett's Esophagus (BE). This is done by the collection and analysis of the medical record information, imaging data, and pathology results. The information is then stored and may be used at a later time for various future analyses and publications. Any future analyses involving this Study will only use the information collected in this Study. No further involvement or additional informed consent of participants will be needed if future analyses are performed.
This Study is designed for participants who have a prior biopsy-confirmed diagnosis of BE with dysplasia and are scheduled to have an endoscopic evaluation of your esophagus for BE surveillance by a standard procedure called EGD (esophagogastroduodenoscopy) as well as an imaging procedure called VLE (volumetric laser endomicroscopy).
The NvisionVLE® Imaging System is cleared for use by the U.S. Food and Drug Administration (FDA).
Patients who undergo an endoscopic evaluation of the esophagus with the NvisionVLE® Imaging System at participating hospitals will be invited to participate in this Study. The Study is taking place at up to 4 hospitals, and as many as 100 patients may participate in this Study.
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
- •Patients over the age of
- •Patients undergoing an upper endoscopy for BE surveillance with prior biopsy-confirmed BE with dysplasia (at least LGD).
- •Ability to provide written, informed consent.
- •No significant esophagitis (LA grade < B, C and D).
排除标准
- •Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
- •Patients without visible BE at time of study EGD.
- •Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
- •Prior esophageal or gastric surgical resection.
- •Significant esophageal stricture requiring dilatation.
- •Patients who require anticoagulation for whom biopsy would be contraindicated.
- •Patients who are known to be pregnant.
结局指标
主要结局
Performance of manually identified VLE features in predicting biopsy defined dysplasia
时间窗: Up to 2 years post data collection
To determine the per-biopsy performance of a multivariable model consisting of manually-identified VLE features for predicting biopsy-defined dysplasia
次要结局
- Per Patient Sensitivity and specificity for detecting dysplasia(Up to 2 years post data collection)
- Per Biopsy performance of VLE compared to standard-of-care for detecting dysplasia(Up to 2 years post data collection)
- Per Biopsy Sensitivity and specificity for detecting dysplasia(Up to 2 years post data collection)