Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432835
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2007-02-07
Brief Title:
Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Sponsor:
University of Mississippi Medical Center
Organization:
University of Mississippi Medical Center
Study Overview
Official Title:
Double-Blind Placebo-Controlled Cross-Over Design With Wash-Out for Temporary Gastric Electrical Stimulation for Drug Refractory Gastroparesis
Status:
COMPLETED
Status Verified Date:
2012-11
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:
None
Brief Summary:
The purpose of this research is to determine if temporary gastric electrical stimulation will help improve symptoms of gastroparesis abnormal stomach emptying We hypothesize that when the device is ON Gastrointestinal symptoms will decrease by at least 50 from baseline
Detailed Description:
Gastric Electrical Stimulation is an established treatment for drug-refractory patients who have the symptoms of gastroparesisgastropathy The symptoms of GP are nausea vomiting anorexiaearly satiety bloatingdistention and abdominal pain and are classically associated with delayed gastric emptying of solids The technique of GES was first used in a patient seen at University of Tennesse-Memphis in 1993 and has undergone several clinical trials particularly the GEMS trial a feasibility trial starting in 1995 and the WAVESS trial a double-blind trial begun in 1997 Both were international trials showing promising results and both have been published in the last 2 years However a number of issues related to who would benefit the most from Gastric Electrical Stimulation therapy have emerged Among these issues are whether patients with etiologies other than diabetic or idiopathic gastroparesis such as post-surgical gastropathy which is often related to rapid not delayed gastric emptying could be helped
Most recently a technique for the temporary placement of a Gastric Electrical Stimulation electrode in the stomach with an upper endoscope combined with an external Gastric Electrical Stimulation device has been tried and validated first at UAMS in Little Rock AR beginning in 2001 and more recently here at UMMC beginning later in 2001 and up until the present time Using the technique of temporary gastric electrical stimulation we have been able to demonstrate that TempStim can quickly demonstrate in a manner of days that a patient will respond to temporary GES as quantified by a decrease in GI total symptoms and an improvement and normalization in solid gastric emptying
Most recently a technique for the temporary placement of a Gastric Electrical Stimulation electrode in the stomach with an upper endoscope combined with an external Gastric Electrical Stimulation device has been tried and validated first at UAMS in Little Rock AR beginning in 2001 and more recently here at UMMC beginning later in 2001 and up until the present time Using the technique of temporary gastric electrical stimulation we have been able to demonstrate that TempStim can quickly demonstrate in a manner of days that a patient will respond to temporary GES as quantified by a decrease in GI total symptoms and an improvement and normalization in solid gastric emptying
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