A STUDY OF CRYOSPRAY ABLATIONTM USING SURGICAL RESECTION SPECIMENS TO DETERMINE TREATMENT EFFECT, DEPTH OF INJURY, AND SIDE EFFECTS IN THE ESOPHAGUS (CSA Depth 3)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Depth of Injury
研究概览
简要总结
The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.
详细描述
The proposed study is a single center study consisting of no more than 10 subjects who are undergoing scheduled esophagectomy for reasons unrelated to the study. Subjects will be divided into 2 Groups in a sequential fashion based on the time of enrollment (Subject 1 in Group1, Subject 2 in Group 2, Subject 3 in Group1, Subject 4 in Group 2, etc). Potential study subjects will be referred from clinical practice. After entry into the study with written informed consent, subjects will be scheduled for the EGD with cryospray ablation treatment 7 days prior to the expected esophagectomy date.
All subjects will receive narcotic analgesics to control symptoms.
Endpoints related to pathology will be assessed by two independent reviewers, one from the Institution's Department of Pathology, and one from an independent Pathology lab chosen by the sponsor. The reviewers will evaluate the pathology slides to assess maximal extent of depth of injury, side effects, and pathological changes associated with CSA. All reviewers will be blinded to the treatment conditions of the specimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18 years of age
- •Esophagectomy planned based on clinical situation not related to this study.
- •Deemed operable based on institutional criteria.
排除标准
- •Esophageal stricture preventing passage of endoscope or catheter.
- •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.
- •Refusal or inability to give consent.
- •Concurrent chemotherapy.
- •Prior or concurrent endoscopic ablation therapy within 4 cm from the CSA treatment area including, but not limited to, cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation, or argon plasma coagulation.
- •Prior radiation therapy which involved the esophagus.
研究组 & 干预措施
Group 1: Cryo Spray Ablation
cryo spray ablation applied to healthy tissue 4 cycles x 10 seconds
干预措施: Cryo Spray Ablation (Device)
Group 2: Cryo Spray Ablation
cryo spray ablation applied to healthy tissue 2 cycles x20 seconds
干预措施: Cryo Spray Ablation (Device)
结局指标
主要结局
Depth of Injury
时间窗: End of Study
histopathological findings analyzed to determine max depth of injury (mm)
次要结局
- Side Effects of Subjects Receiving Cryospray Therapy.(End of Study)