GERD Clinical Trial
Official title:
An Investigation of Electrical Stimulation on Gastroesophageal Reflux Disease (GERD) in Patients After Sleeve Gastrectomy
Sleeve gastrectomy (SG) has gained popularity as both a staged and a definitive procedure
for morbid obesity due to its technical simplicity, low-morbidity and excellent results both
for weight loss and control of metabolic syndrome. There are however reports of SG worsening
pre-existing GERD or causing new-onset GERD. Because of this, patients with pre-existing
GERD have been denied the benefits of SG. In addition, patients that develop post-op GERD
cannot undergo traditional anti-reflux surgery since the gastric fundus that is required for
fundoplication is removed during the SG. Hence, patients with post-SG GERD not adequately
controlled with medication can only opt for the more invasive gastric bypass procedure as
their only surgical treatment option.
In a recently reported case study, an obese patient with severe GERD successfully treated
with EndoStim underwent SG and maintained adequate GERD control with continued use of LES
stimulation therapy. However electrical stimulation was not yet tested systematically in
patients with prior gastric operation such as sleeve gastrectomy.
This study will test the hypothesis that electrical stimulation is effective in control of
GERD associated with SG.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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