An Investigation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD)

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

a. Subject is between 21 - 65 years of age.
b. Subject has a history of heartburn, regurgitation or both for >6 month prompting physician
recommendation of continual daily use of PPI before study entry. Baseline GERD HRQL
heartburn score of >= 20 off PPI assessed during the run in phase.
c. Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or
II (or comparable local classification if any).
d. Subject has demonstrated satisfactory symptomatic response to a previous course of GERD
therapy (>= 2 weeks). GERD HRQL heartburn score improvement of > 10 on therapy as
assessed within 6 weeks of enrollment.
e. Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry of
antisecretory therapy performed within 6 months of enrollment; pH < 4 for > 5% of total time or >
3% of supine time.
f. Subject has a resting LES end expiratory pressure > 5mm Hg and < 15 mm Hg on a high
resolution manometry within 6 months of enrollment.
g. Subject has esophagitis <= Grade C (LA classification) on upper endoscopy within 6 months of
enrollment.
h. Subject has esophageal body contraction amplitude > 30 mmHg for >70% of swallows and >
50% peristaltic contractions on high resolution manometry.
i. Subject has signed the informed consent form.

Exclusion Criteria

a. Subject has any non-GERD esophageal motility disorders.
b. Subject has gastroparesis.
c. Subject has any significant multisystem diseases.
d. Subject has an autoimmune or a connective tissue disorder (e.g. scleroderma,
dematomyositis, Calcinosis-Raynaud*s-Esophagus Sclerodactyly Syndrome (CREST),
Sjogren*s Syndrome, Sharp*s Syndrome) requiring therapy in the preceding 2 years.
e. Subject has Barrett*s epithelium (> M2; >C1) or any grade of dysplasia.
f. Subject has a hiatal hernia larger than 3 cm.
g. Subject has a body mass index (BMI) greater than 35 kg/m2.
h. Subject has Type 1 diabetes mellitus
i. Subject has uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c >9.5 in the
previous 6 months, or has T2DM for > 10 years.
j. Subject has a history of suspected or confirmed esophageal or gastric cancer.
k. Subject has esophageal or gastric varices.
l. Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
m. Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
n. Subject requires chronic anticoagulant therapy.
o. Subject has dysphagia or esophageal peptic stricture, excluding Schatzki*s ring.
p. Subject is pregnant or intends to become pregnant during the trial period.
q. Subject is currently enrolled in other potentially confounding research.
r. History of any malignancy in the last 2 years.
s. History of previous esophageal or gastric surgery, including nissen fundoplication.
t. Subject has any condition that, at the discretion of the investigator or sponsor, would preclude
participation in the trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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