Viewing Study NCT01110811



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Last Modification Date: 2024-10-26 @ 10:19 AM
Study NCT ID: NCT01110811
Status: COMPLETED
Last Update Posted: 2019-03-06
First Post: 2010-04-23

Brief Title: Transoral Incisionless Fundoplication TIF Versus Sham for Treatment of Gastroesophageal Reflux Disease GERD
Sponsor: EndoGastric Solutions
Organization: EndoGastric Solutions

Study Overview

Official Title: A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication TIF Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD the TIF vs Sham Study
Status: COMPLETED
Status Verified Date: 2019-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The study objective is to evaluate the relative merits safety and effectiveness of transoral incisionless fundoplication TIF in proton pump inhibitor PPI dependent GERD patients compared with sham procedure
Detailed Description: Primary Effectiveness Endpoint The proportion of patients in clinical remission after 6 months without being classified as treatment failure

Secondary Effectiveness PPI consumption esophageal acid exposure reduction in QOLRAD and GSRS scores and healing of reflux esophagitis

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None