Ignite Creation Date:
2024-05-05 @ 10:06 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01025739
Status:
WITHDRAWN
Last Update Posted:
2015-04-29
First Post:
2009-12-02
Brief Title:
Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication TIF Using EsophyX for the Treatment of GERD
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Phase II Study of Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication TIF Using EsophyX for the Treatment of GERD
Status:
WITHDRAWN
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No funding source for device purchasing
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives of the Study
The primary objective of this study is to evaluate the relative merits safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy
The secondary objective of the study is to evaluate the effectiveness of the tailored TIF procedure in restoring the antireflux barrier and eliminating GE reflux
Type of Study
Prospective non-randomized uncontrolled Study Duration 12 months Number of Patients 20
Inclusion Criteria
Age 18-70 years on daily PPIs for 6 months persistent GERD symptoms despite PPI therapy anatomic disruption of the gastroesophageal valve to a Hill Grade II-III evidence of one of the following while on PPI therapy 1 erosive esophagitis erosions or ulcerations during endoscopy 2 abnormal ambulatory pH study or 3 biopsy confirmed changes characteristic of reflux esophagitis acceptable esophageal motility by either manometry or video esophagogram hiatal hernia no larger than 2 cm patient willing to cooperate with post-operative dietary recommendations and assessment tests signed informed consent
Exclusion Criteria
BMI 40 hiatal hernia 2 cm esophagitis grade D esophageal ulcer fixed esophageal stricture gastric motility disorders previous splenectomy pregnancy female immunosuppression ASA 2 portal hypertension andor varices history of previous resective gastric or esophageal surgery cervical spine fusion Zenkers diverticulum esophageal epiphrenic diverticulum achalasia scleroderma or dermatomyositis eosinophilic esophagitis or cirrhosis active gastro-duodenal ulcer disease gastric outlet obstruction or stenosis gastroparesis or delayed gastric emptying coagulation disorders
Interventions
Treatment Tailored transoral incisionless fundoplication TIF2 using EsophyX system with SerosaFuse fasteners EndoGastric Solutions Inc Redmond WA USA
Evaluation Criteria
Primary Outcome Measure 24 hour pH impedance study change in Johnson DeMeester scores GERD-HRQOL scores Secondary Outcome Measures PPI usage GERD symptoms at 6 and 12 months vs baseline off PPIs total number of reflux episodes and Symptom Association Probability while off PPI
Safety Adverse events will be mapped to standard terms and reported
The primary objective of this study is to evaluate the relative merits safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy
The secondary objective of the study is to evaluate the effectiveness of the tailored TIF procedure in restoring the antireflux barrier and eliminating GE reflux
Type of Study
Prospective non-randomized uncontrolled Study Duration 12 months Number of Patients 20
Inclusion Criteria
Age 18-70 years on daily PPIs for 6 months persistent GERD symptoms despite PPI therapy anatomic disruption of the gastroesophageal valve to a Hill Grade II-III evidence of one of the following while on PPI therapy 1 erosive esophagitis erosions or ulcerations during endoscopy 2 abnormal ambulatory pH study or 3 biopsy confirmed changes characteristic of reflux esophagitis acceptable esophageal motility by either manometry or video esophagogram hiatal hernia no larger than 2 cm patient willing to cooperate with post-operative dietary recommendations and assessment tests signed informed consent
Exclusion Criteria
BMI 40 hiatal hernia 2 cm esophagitis grade D esophageal ulcer fixed esophageal stricture gastric motility disorders previous splenectomy pregnancy female immunosuppression ASA 2 portal hypertension andor varices history of previous resective gastric or esophageal surgery cervical spine fusion Zenkers diverticulum esophageal epiphrenic diverticulum achalasia scleroderma or dermatomyositis eosinophilic esophagitis or cirrhosis active gastro-duodenal ulcer disease gastric outlet obstruction or stenosis gastroparesis or delayed gastric emptying coagulation disorders
Interventions
Treatment Tailored transoral incisionless fundoplication TIF2 using EsophyX system with SerosaFuse fasteners EndoGastric Solutions Inc Redmond WA USA
Evaluation Criteria
Primary Outcome Measure 24 hour pH impedance study change in Johnson DeMeester scores GERD-HRQOL scores Secondary Outcome Measures PPI usage GERD symptoms at 6 and 12 months vs baseline off PPIs total number of reflux episodes and Symptom Association Probability while off PPI
Safety Adverse events will be mapped to standard terms and reported
Detailed Description:
None
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