Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing the Tissue Response to Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions
研究概览
简要总结
The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.
详细描述
This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.
Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.
Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 with a diagnosis of Barrett's esophagus
- •Patients undergoing an Esophagogastroduodenoscopy (EGD)
- •Patients scheduled for treatment with RF ablation or patients that have had previous BARRX RF ablation
- •Patients must be over the age of 18
- •Patient must be able to give informed consent
- •Women with child bearing potential must have a negative pregnancy test prior to procedure
排除标准
- •Patients on oral anticoagulation medications
- •Patients with a history of hemostasis disorders
- •Patients that are pregnant
- •Patients with esophageal strictures
研究组 & 干预措施
MGH OFDI Imaging
OFDI imaging
干预措施: MGH OFDI Imaging (Device)
结局指标
主要结局
Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions
时间窗: During the OFDI imaging session (about 5 minutes)
Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Professor of Pathology
Massachusetts General Hospital