NCT02953418终止不适用
A Multicenter Trial of Endoscopic Radiofrequency Ablation for High-grade and Low-grade Intraepithelial Squamous Neoplasia Using the Barrx™ Flex Radiofrequency Ablation System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Percentage of Subjects With Complete Response (CR)
研究概览
简要总结
Multicenter, prospective cohort clinical trial in greater China
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18-85 years of age
- •Patient has evidence of ESCN, within the last 3 months, patient demonstrated a new diagnosis or a reconfirmed diagnosis of squamous MGIN and/or HGIN of the esophagus
- •On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and greater than ¼ of the esophageal circumference and has MGIN or HGIN on biopsy, confirmed by central pathologist
- •All lesions in the esophagus are completely flat (Paris type 0-IIb), both on WLE and Lugol's chromoendoscopy
- •The maximum allowable linear length of "USL-bearing esophagus" is 12 cm
- •Baseline endoscopic ultrasound (EUS) (if applicable) shows no exclusionary findings for the trial
- •Computed Tomography )CT( scan of chest and upper third of the abdomen (if applicable) shows no exclusionary findings for the trial
- •Based on the judgment of the study endoscopist, the patient is eligible for treatment, follow-up endoscopy, and biopsy as required by the protocol
- •EMR or ESD occurred > 3 months before enrollment, patients may be eligible for the study if procedure was curative (negative margins and no risk of lymph node involvement) and the patient has no other findings concerning for cancer
- •The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation
排除标准
- •Patient has esophageal squamous cell carcinoma (ESCC)
- •Any non-flat (Paris type 0-I, 0-IIa, 0-IIc, 0-III) abnormalities anywhere in the esophagus
- •Any abnormalities under WLE, Lugol's chromoendoscopy or NBI that are suspicious for ESCC anywhere in the esophagus (e.g. 'pink sign' USL, defined as a color change after Lugol's staining: initially whitish yellow and pink 2-3 minutes later)
- •Any USL with MGIN or worse on biopsy outside the treatment area
- •Esophageal stricture preventing passage of a therapeutic endoscope
- •Prior endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) which occurred < 3 months before enrollment
- •Any esophageal dilation in the past 12 months
- •Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage)
- •Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other) or any radiation therapy to the esophagus
- •Previous esophageal surgery, except fundoplication without complications (i.e., no slippage, dysphagia, etc.)
- •Evidence of esophageal varices detected within last 6 months or at initial RFA procedure
- •Patient has active reflux esophagitis grade C or D
- •Evidence of eosinophilic esophagitis on endoscopy and/or histology
- •Inner diameter of the esophagus measuring <18 mm
- •Report of uncontrolled coagulopathy with international normalized ratio (INR) > 2 or platelet count <75,000 platelets per µL (note: a complete blood count is not required for all subjects in this study)
- •Patient is using anti-thrombotic agents that cannot be discontinued 7 days before and after therapeutic sessions
- •Patient has an implantable pacing device (examples: automated implantable cardioverter defibrillator, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
- •Patient has life expectancy less than 5 years
- •Patient suffers from psychiatric or other illness and/or has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post- treatment instructions, or follow-up guidelines
- •Patient is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
- •The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
- •Patient is pregnant or has plans to become pregnant in the ensuing 12 months (confirmation of non-pregnant status in women of child-bearing age and ability required with urine or blood test to be eligible)
结局指标
主要结局
Percentage of Subjects With Complete Response (CR)
时间窗: 12 month
The primary endpoint is the percentage of subjects with "complete response (CR)", defined as complete eradication of squamous histological abnormalities (MGIN or worse) within the treatment area (TA) at 12 months after the initial treatment session
次要结局
- Complete Response Within the Treatment Area(3, 6 and 12 Month)
- Disease Progression Outside the Treatment Area(Initial, 3, 6, 9 and 12 month)
- Complete Response at Three Months(3 Months)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine NeoplasmsPancreatic Neuroendocrine Tumors, WHO Grade I-IINCT05243082Oslo University Hospital20
进行中（未招募）
不适用
EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)Pancreatic InsulinomaNCT05735912Azienda Ospedaliera Universitaria Integrata Verona60
已完成
不适用
Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early AdenocarcinomaBarrett's EsophagusNCT01961778Massachusetts General Hospital50
已完成
不适用
A Multi-Center, Prospective Study of endoscopic shincterotomy combined with large balloon dilation for removal of difficult common bile duct stonesDifficult common bile duct stonesJPRN-UMIN000008275Chiba University Hospital100
招募中
不适用
Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE StudyPancreatic NeoplasmNCT05961982Ohio State University Comprehensive Cancer Center84