跳至主要内容
临床试验/NCT02354716
NCT02354716终止不适用

Expanding the Clinical Applications of Functional Luminal Imaging (EndoFLIP) in Esophageal Stenoses

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
1
主要终点
Collection of Measurements of the Luminal Narrowing Using EndoFlip

研究概览

简要总结

The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation.

详细描述

To date there is no effective way to objectively characterize and predict response to endoscopic dilation of luminal strictures of the GI tract. Endoscopic dilation allows effective remediation of benign esophageal and upper GI tract strictures. Stricture dilation is performed after the stricture diameter is crudely gauged by the endoscopist. Stricture characteristics are based on the severity of symptoms and appearance. A stricture may be graded as mild, moderate, severe and as to whether or not the endoscope is able to traverse the luminal narrowing. By precisely measuring the diameter and length of a stricture, the endoscopist can know exactly what type of dilation is necessary. Benign esophageal strictures may also be refractory to dilation and thus require multiple sessions, prior to achieving successful remediation. The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation. The study will include patients with strictures referred for endoscopic dilation for the following indications: radiation induced strictures, peptic strictures, RFA induced strictures, EMR induced strictures, eosinophilic esophagitis, Zenkers diverticulum, and strictures related to surgical anastomoses. In patients with benign refractory esophageal strictures referred for endoluminal prostheses EndoFLIP will be used to characterize the stricture prior to stent placement.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > or = to 18 years of age
  • Referred for evaluation and treatment of benign esophageal luminal narrowing
  • Clinical diagnosis of benign esophageal luminal narrowing with documentation and imaging
  • Adult patients with benign refractory esophageal strictures referred for placement of an esophageal stent are eligible for this study
  • Willing and able to give informed consent
  • No condition or comorbidity which would prevent the patient from undergoing a successful upper endoscopy

排除标准

  • < 18 years of age
  • Pregnancy
  • History of prior endoscopic dilation* (*unless referred for placement of stent)
  • Coagulopathy
  • Inability to traverse the stricture using standard techniques
  • Patients unable to provide consent

结局指标

主要结局

Collection of Measurements of the Luminal Narrowing Using EndoFlip

时间窗: 12 Months

The study is observational and a proof of concept study. Measurements of the luminal narrowing using EndoFLIP will be obtained.

次要结局

  • Observation of Pre-Endoscopic Therapy EndoFLIP Measurements(12 Months)
  • Observation of Post-Endoscopic Therapy EndoFLIP Measurements(12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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