Ignite Creation Date:
2024-05-05 @ 10:28 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01118585
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2010-04-30
Brief Title:
Transoral Incisionless Fundoplication TIF Registry Study for Treatment of Gastroesophageal Reflux Disease GERD
Sponsor:
EndoGastric Solutions
Organization:
EndoGastric Solutions
Study Overview
Official Title:
Prospective Outcome Evaluation of Transoral Incisionless Fundoplication TIF for the Treatment of Gastroesophageal Reflux Disease GERD The TIF Registry 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 safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States
Detailed Description:
Primary Effectiveness Endpoint Typical and atypical GERD symptom elimination scores 2 to each question or clinically significant improvement 50 reduction in total scores at 6-month follow-up compared to baseline
Secondary Effectiveness Endpoints GERD symptom elimination or clinically significant improvement at 12-month follow-up 24-month follow-up and 36-month follow-up complete discontinuation of PPIs normalization of esophageal acid exposure significant reduction in reflux episodes healing of reflux esophagitis reduction of hiatal hernia safety supported by low incidence of serious adverse events
Secondary Effectiveness Endpoints GERD symptom elimination or clinically significant improvement at 12-month follow-up 24-month follow-up and 36-month follow-up complete discontinuation of PPIs normalization of esophageal acid exposure significant reduction in reflux episodes healing of reflux esophagitis reduction of hiatal hernia safety supported by low incidence of serious adverse events
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