Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Barrett's Esophagus
- 发起方
- Massachusetts General Hospital
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .
详细描述
Three hundred consenting patients undergoing routine esophagogastroduodenoscopy (EGD) procedures will be recruited for examination at the gastroesophageal junction with our developed OCT imaging system. The patients will undergo a clinical EGD procedure including endoscopic biopsy. The first step in the procedure follows the standard care with the performance of the surveillance endoscopy. The study experimental procedure will then begin. This study requires the use of a balloon . The balloon placement method is in accordance with current standard clinical practice and involves the insertion of a guide wire through the auxiliary channel of the endoscope. The endoscope is then removed, leaving the guide wire in place, and the OCT balloon is inserted the required distance (determined during the endoscopy) over the guide wire to the GE junction. The OCT balloon will then be inflated and will remain in this fixed position throughout the entire procedure. Once the OCT imaging probe is in place, OCT image data will be continuously collected over the length of the balloon(approximately 5 cm). It is expected that the total examination time including insertion and inflation of the OCT balloon, OCT imaging and removal of the OCT balloon will add no more than 10 minutes to the total length of the EGD.
研究者
Guillermo Tearney
Professor of Pathology
Massachusetts General Hospital
入排标准
入选标准
- •over the age of 18,
- •capable of giving informed consent,
- •are undergoing elective EGD, and
- •if female are willing to take a pregnancy test
排除标准
- •patients on oral anticoagulation medications,
- •with a history of hemostasis disorders and
- •patients that are pregnant
结局指标
主要结局
Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening
时间窗: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.