Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-01-24 @ 9:12 PM
Study NCT ID:
NCT02514616
Status:
TERMINATED
Last Update Posted:
2015-11-20
First Post:
2015-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (GERD)
Sponsor:
Erasme University Hospital
Organization:
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 weeks/randomization, 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 weeks/randomization, 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:
False
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?: