临床试验/NCT04306380

NCT04306380Enrolling By Invitation不适用

Transoral Incisionless Fundoplication Database Repository (TIF)

Indiana University1 个研究点分布在 1 个国家目标入组 500 人开始时间: 2020年5月20日最近更新: 2026年2月24日

适应症

试验速览

阶段: 不适用
状态: Enrolling By Invitation
发起方: Indiana University
入组人数: 500
试验地点: 1
主要终点: GERD-Health Related Quality of Life Questionnaire (GERD_HRQL)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Collect data on individuals who have a transoral incisionless fundoplication (TIF) performed by physicians at Indiana University for the treatment of gastroesophageal reflux disease.

详细描述

Collect patient information related to transoral incisionless fundoplication (TIF) done for gastroesophageal reflux disease. The database information with be used for research to assess trends improve patient care.

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: 13 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Having a TIF procedure completed at Indiana University Health, University Hospital

排除标准

•under 13 years of age

结局指标

主要结局

GERD-Health Related Quality of Life Questionnaire (GERD_HRQL)

时间窗: baseline; 6,12,24 and 60 months

Change in score for questionnaire related to quality of life with GERD

RESQ-7 questionnaire

时间窗: baseline; 6,12,24 & 60 months

Change in score for questionnaire related to symptoms of GERD

次要结局

未报告次要终点

研究者

发起方

Indiana University

申办方类型

Other

责任方

Principal Investigator

主要研究者

John DeWitt

Associate Professor of Medicine

Indiana University

研究点 (1)

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