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临床试验/NCT01003743
NCT01003743已完成不适用

Endolumenal Gastric Pouch and Gastrojejunal Anastomosis Reduction

USGI Medical2 个研究点 分布在 1 个国家开始时间: 2009年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
试验地点
2

研究概览

简要总结

Registry is designed to evaluate use of endolumenal tissue anchors for soft tissue approximation to repair a dilated gastric pouch and gastrojejunal anastomosis in post-Roux-En-Y gastric bypass patients presenting with weight regain. Registry will also assess tissue anchor durability.

研究设计

研究类型
Interventional

入排标准

年龄范围
19 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is > 18 years of age and < 65 years of age
  • Patient is > 2 yrs post-Roux-en-Y bypass surgery
  • Patient initially achieved > 50% EWL after Roux-en-Y bypass surgery
  • Patient is a reasonable risk to undergo general anesthesia
  • Patient is able to provide written informed consent

排除标准

  • Patient has an esophageal stricture or other anatomy/condition that would preclude the use and passage of the endolumenal instruments
  • Physician determines another causal factor for weight regain other than stoma or pouch dilation
  • Patient is non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise

研究者

发起方
USGI Medical
申办方类型
Industry

研究点 (2)

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