Ignite Creation Date:
2024-05-06 @ 7:18 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02514616
Status:
TERMINATED
Last Update Posted:
2015-11-20
First Post:
2015-07-24
Brief Title:
Electrical Stimulation Therapy EST of the Lower Esophageal Sphincter GERD
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
Electrical Stimulation Therapy EST of the Lower Esophageal Sphincter a Multicenter Randomized Double-blind Sham-controlled Parallel-group Trial Evaluating Short Term Efficacy of EndoStim Device on GERD
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early termination due to a suspension of financial support
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EST-SHAM-EUR
Brief Summary:
The investigational device that will be used in this trial is the EndoStim Lower Esophageal Sphincter LES Stimulation System
The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy EST on the lower esophageal sphincter LES in the treatment of subjects with gastroesophageal reflux disease GERD
The study population will consist of subjects diagnosed with pathological GERD as defined by abnormal pH and who complain of heartburn regurgitation or both for 6 months on a daily PPI use
The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy EST on the lower esophageal sphincter LES in the treatment of subjects with gastroesophageal reflux disease GERD
The study population will consist of subjects diagnosed with pathological GERD as defined by abnormal pH and who complain of heartburn regurgitation or both for 6 months on a daily PPI use
Detailed Description:
Study Design
Multicenter randomized double-blind sham-controlled study All subjects undergo screening and baseline visits followed by system implantation and randomization after 2 weeks to either a treatment Group stimulation or Control Group delayed stimulation
Randomized subjects complete a 10-week double-blind phase At the 14-week visit subjects are unblinded control group subjects begin receiving stimulation and all subjects are followed for an additional 9-month open-label treatment phase
Subjects continue receiving stimulation for an extended follow-up phase involving annual visits through 5 years
Study Visits
Screening and baseline visits Laparoscopic implantable pulse generator IPG and lead implant procedure Post-implant follow-up office visits at 2 weeksrandomization 6 10 14 24 and 48 weeks followed by annual visits through 5 years
Sample Size and Scope
Forty-six subjects will be implanted and followed to 12 months after stimulation treatment at 3 investigational sites
Multicenter randomized double-blind sham-controlled study All subjects undergo screening and baseline visits followed by system implantation and randomization after 2 weeks to either a treatment Group stimulation or Control Group delayed stimulation
Randomized subjects complete a 10-week double-blind phase At the 14-week visit subjects are unblinded control group subjects begin receiving stimulation and all subjects are followed for an additional 9-month open-label treatment phase
Subjects continue receiving stimulation for an extended follow-up phase involving annual visits through 5 years
Study Visits
Screening and baseline visits Laparoscopic implantable pulse generator IPG and lead implant procedure Post-implant follow-up office visits at 2 weeksrandomization 6 10 14 24 and 48 weeks followed by annual visits through 5 years
Sample Size and Scope
Forty-six subjects will be implanted and followed to 12 months after stimulation treatment at 3 investigational sites
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