跳至主要内容
临床试验/NCT04752670
NCT04752670已完成不适用

Prospective Registry of Submucosal Endoscopic Procedures Performed by a Novel Electrosurgical Unit

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Technical Success rate

研究概览

简要总结

This is a prospective registry of all patients who endoscopic submucosal dissection (ESD), per-oral endoscopic myotomy (POEM) and gastric per-oral endoscopic myotomy (G-POEM) using ConMed Electrosurgical unit for submucosal Dissection at Baylor St Luke's Medical Center. Collected information includes; procedure technical success rate, duration, periprocedural complications and ease of use.

详细描述

Submucosal endoscopy is a novel subset of procedures which enables endoscopist to utilize the submucosal space to perform advanced endoscopic procedures. The submucosa is the third layer of the gastrointestinal wall and it is a potential space which is expandable upon injecting the submucosa with fluid. The expanded submucosa causes a significant lift which enable dissection of the submucosal space with the removal of the overlying polyp or early cancer. The submucosal space can be also utilized to create a longitudinal submucosal tunnel in the esophagus or the stomach wall which allows for performing lower esophageal sphincter or pyloric myotomy for the treatment of achalasia or Gastroparesis.

Currently, the most commonly performed submucosal endoscopy procedures are endoscopic submucosal dissection (ESD) for removal of early cancers or polyps throughout the gastrointestinal tract, Per-oral Endoscopic Myotomy (POEM) for treatment of achalasia, or Gastric Per-Oral Endoscopic myotomy for the treatment of Gastroparesis. All of the above procedures require a specialized electrosurgical unit (ESU) which generate high frequency current to help incision (cutting) of the mucosa and dissection (coagulation) of the submucosa. The ConMed Beamer is a novel ESU with tissue sensing property which expedites the process of submucosal dissection. The device is currently approved for clinical use in the US. The purpose of this study is to create registry for all submucosal endoscopy procedures performed using ConMed Beamer device at BSLMC with focus on clinical outcomes of the procedure including adverse events.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is ≥ 18 years old
  • Patient is capable of providing informed consent
  • Patient is referred for endoscopic submucosal dissection, per-oral endoscopic myotomy, or gastric per-oral endoscopic myotomy

排除标准

  • Patient is < 18 years old
  • Patient refused and/or unable to provide consent
  • Patient is a pregnant woman

结局指标

主要结局

Technical Success rate

时间窗: 1 year

Defined as the ability to perform the entire procedure using the ConMed Beamer electrosurgical system

次要结局

  • Adverse Events(1 year)
  • Procedure Time(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Othman

M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section

Baylor College of Medicine

研究点 (1)

Loading locations...

相似试验