A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Gastroesophageal Reflux Disease (GERD)
- Conditions
- acid refluxGastroesopahegeal Reflux Disease (GERD)10017947
- Registration Number
- NL-OMON45265
- Lead Sponsor
- Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Subject is 22 * 75 years of age at the time of informed consent
Subject with documented symptoms of GERD for longer than 6 months (regurgitation and/or heartburn which is defined as burning epigastric or substernal pain which responds to acid neutralization or suppression) which requires daily use of proton pump inhibitors (PPIs) or other antireflux drug therapy, who continue to have symptoms despite maximum medical therapy or are *intolerant* severe
sideeffects (e.g. anaphylaxis or severe allergic reaction, recurrent C. difficile, severe hypomagnesaemia) to one PPI or mild/moderate side effect (e.g.
nausea, vomiting, diarrhea or abdominal pain) to at least 2 PPIs of different chemical classes. Subjects with symptomatic improvement on PPI therapy demonstrated by a composite GERDHRQL score of *20 off PPI, and with *10 point improvement on PPI when comparing to their off PPI composite GERDHRQL score.
Subject has exhibited excessive lower esophageal acid exposure during pH monitoring (defined as distal esophageal pH < 4 for > 6.0% of the monitoring time) performed after at least 5 days off of PPIs and at least 2 days off of H2 blockers.
Subject has esophagitis * Grade B (LA classification) as measured by upper endoscopy off PPI and H2 blockers for at least 10 days.
Exclusion Criteria
Subjects must not meet any of the following study exclusion criteria:
a. Subject had a previous EndoStim LES System implant and/or implant attempt
b. Subject underwent previous surgery involving the gastroesophageal junction or the lead implant site, such as a Nissen fundoplication
c. Subject underwent previous endoscopic intervention for the treatment of GERD and/or Barrett*s esophagus
d. Subject has a hiatal hernia larger than 3 cm as determined by endoscopy
e. Subject has history of gastroparesis
f. Subject has any nonGERD esophageal motility disorders that in the opinion of investigator precludes an antireflux procedure
g. Subject has history of or known esophageal stricture or significant esophageal anatomic abnormalities (obstructive lesions, etc.)
h. Subject has Barrett*s esophagus or any grade of dysplasia
i. Subject has documented history of esophagitis Grade C or D (LA Classification)
j. Subject has a history of suspected or confirmed esophageal or gastric cancer
k. Subject has esophageal or gastric varices
l. Subject has symptoms of dysphagia more than once per week every week within the last 3 months
m. Subject is unable to tolerate withdrawal from H2 Blockers or PPI medications
n. Subject has suspected or known allergies to titanium, platinum, iridium, stainless steel, silicone, epoxy, or nylon
o. Subject has a body mass index (BMI) > 35 kg/m2
p. Subject has any significant multisystem diseases
q. Subject has an autoimmune or a connective tissue disorder (scleroderma, dematomyositis, CalcinosisRaynaud*sEsophagus Sclerodactyly Syndrome (CREST), Sjogren*s Syndrome, Sharp*s Syndrome, etc.) requiring therapy in the preceding 2 years
r. Subject has Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c > 9.5 in the previous 6 months or at screening/baseline
s. Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease (i.e. unstable angina pectoris, hemodynamically significant valvular disease, severe congestive heart failure), or any cardiac therapeutic intervention within the last 6 months.
t. Subject has had a significant cerebrovascular event within the last 6 months
u. Subject has an existing implanted electrical stimulator (pacemaker, implantable cardioverter defibrillator, DBS, bone growth or pelvic floor stimulators, drug pumps, etc.)
v. Female subject of childbearing potential and is pregnant or nursing, or intends to become pregnant during the trial period, who is not using a reliable form of birth control
w. Subject is currently enrolled in other potentially confounding research
x. Subject has an active infection as determined by the investigator
y. Subject has a history of any malignancy in the last 2 years
z. Subject has a life expectancy less than 3 years
aa. Subject has a diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.)
bb. Subject has any condition that, at the discretion of the investigator or sponsor, would interfere with accurate interpretation of the study endpoints or preclude participation in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety Endpoint: Rate of occurrence of device- and/or procedure-related serious<br /><br>adverse events at the 12-month follow-up visit as adjudicated by the Data<br /><br>Safety Monitoring Board with a sufficient level of precision<br /><br>Efficacy Endpoint: Comparison between treatment and control group of percentage<br /><br>(%) of subjects achieving pH success defined as a normalization (distal<br /><br>esophageal pH < 4 for no more than 5.3% of monitoring time) or > 50%<br /><br>improvement in their distal esophageal pH at 6 months compared to their<br /><br>baseline distal esophageal pH performed after at least 5 days off PPIs and at<br /><br>least 2 days off H2 blocker.</p><br>
- Secondary Outcome Measures
Name Time Method