Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01647958
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2012-06-22
Brief Title:
The EndoGastric Solutions TEMPO Trial
Sponsor:
EndoGastric Solutions
Organization:
EndoGastric Solutions
Study Overview
Official Title:
Transoral Incisionless Fundoplication TIF Versus Medical Proton Pump Inhibitor PPI Management of Refractory Gastroesophageal Reflux Disease GERD Symptoms
Status:
COMPLETED
Status Verified Date:
2020-11
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:
TEMPO
Brief Summary:
The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication TIF performed with EsophyX as compared to proton pump inhibitor PPI therapy for the treatment of chronic Gastroesophageal Reflux Disease GERD patients with refractory symptoms on Proton Pump Inhibitors PPIs
Detailed Description:
The objective of this study is to assess the efficacy and safety of TIF performed with EsophyX as compared to proton pump inhibitor PPI therapy for the treatment of chronic GERD patients with medically refractory GERD symptoms other than heartburn
Primary hypothesis TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms andor troublesome regurgitation if present at 6-month follow-up Secondary hypotheses TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms andor troublesome regurgitation if present at 12- 24- 36- 48- and 60-month follow-up The majority of surgical patients will have normalized or 50 improved esophageal acid exposure compared to baseline at 6-month follow-up The majority of surgical patients will be completely off PPIs at 6- 12- 24- 36- 48- and 60-month follow-up compared to baseline The majority of crossover patients will be completely off PPIs at 6- 18- 30- 42- and 54-month follow-up compared to baseline A statistically greater proportion of crossover patients treated with TIF will be free of daily bothersome symptoms or will experience clinically significant improvement at 6- 18- 30- 42- and 54-month follow-up
Primary hypothesis TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms andor troublesome regurgitation if present at 6-month follow-up Secondary hypotheses TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms andor troublesome regurgitation if present at 12- 24- 36- 48- and 60-month follow-up The majority of surgical patients will have normalized or 50 improved esophageal acid exposure compared to baseline at 6-month follow-up The majority of surgical patients will be completely off PPIs at 6- 12- 24- 36- 48- and 60-month follow-up compared to baseline The majority of crossover patients will be completely off PPIs at 6- 18- 30- 42- and 54-month follow-up compared to baseline A statistically greater proportion of crossover patients treated with TIF will be free of daily bothersome symptoms or will experience clinically significant improvement at 6- 18- 30- 42- and 54-month follow-up
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