Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235677
Status:
COMPLETED
Last Update Posted:
2005-10-10
First Post:
2005-10-06
Brief Title:
Treatment Of Gastroesophageal Reflux Disease By Endoscopic Fundoplication A Placebo-Controlled Study
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
A Blinded Randomized Sham-Controlled Trial of Endoscopic Gastroplication for the Treatment of Gastroesophageal Reflux Disease
Status:
COMPLETED
Status Verified Date:
2005-07
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:
Aim
To evaluate the therapeutic efficacy of a therapeutic procedure involving endoscopic suturing for gastroesophageal reflux disease GERD compared to a sham procedure
The hypotheses tested in this study were that active treatment would 1 decrease the use of antisecretory medication 2 decrease GERD symptoms 3 improve quality of life and 4 reduce esophageal acid exposure
To evaluate the therapeutic efficacy of a therapeutic procedure involving endoscopic suturing for gastroesophageal reflux disease GERD compared to a sham procedure
The hypotheses tested in this study were that active treatment would 1 decrease the use of antisecretory medication 2 decrease GERD symptoms 3 improve quality of life and 4 reduce esophageal acid exposure
Detailed Description:
Gastroesophageal reflux disease GERD and the chronic often lifelong use of antisecretory medication have great clinical and economical implications for the patient practicing physician and society in general The currently available medication in GERD is very effective against heartburn but less against the symptom of regurgitation Surgical antireflux treatment offers a good alternative The current surgical approach a laparoscopic fundoplication is safe and effective a 90 reduction in use of antireflux medication but in a significant subgroup of patients new symptoms arise dysphagia bloating and perioperative morbidity as well as financial costs are relatively high
An endoscopic suturing system has been developed offering a minimally invasive antireflux treatment which can be performed in an outpatient setting The procedure aims to create an endoscopic fundoplication and could possibly serve as an alternative to antireflux medication and surgery Recent uncontrolled studies have shown that the results of the endoscopic suturing system are satisfactory and that the procedure is safe
This single-center double-blinded randomized sham-controlled trial was conducted to evaluate the efficacy of endoscopic gastroplication by the Endocinch suturing system Sixty patients with daily symptoms of GERD and abnormal esophageal 24-hr pH monitoring were randomly assigned to three endoscopic gastroplications n 20 to a sham procedure n 20 or to observation n 20 Primary endpoints were proton pump inhibitor use and GERD symptoms Secondary endpoints were quality of life 24-hr esophageal acid exposure esophageal manometry and the occurrence of adverse events Follow-up assessments were performed at 3 months The research nurse and patients in the active and sham groups were blinded to the procedure assignment
An endoscopic suturing system has been developed offering a minimally invasive antireflux treatment which can be performed in an outpatient setting The procedure aims to create an endoscopic fundoplication and could possibly serve as an alternative to antireflux medication and surgery Recent uncontrolled studies have shown that the results of the endoscopic suturing system are satisfactory and that the procedure is safe
This single-center double-blinded randomized sham-controlled trial was conducted to evaluate the efficacy of endoscopic gastroplication by the Endocinch suturing system Sixty patients with daily symptoms of GERD and abnormal esophageal 24-hr pH monitoring were randomly assigned to three endoscopic gastroplications n 20 to a sham procedure n 20 or to observation n 20 Primary endpoints were proton pump inhibitor use and GERD symptoms Secondary endpoints were quality of life 24-hr esophageal acid exposure esophageal manometry and the occurrence of adverse events Follow-up assessments were performed at 3 months The research nurse and patients in the active and sham groups were blinded to the procedure assignment
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