Status:
UNKNOWN
An Investigation of Electrical Stimulation on Gastroesophageal Reflux Disease (GERD) in Patients After Sleeve Gastrectomy
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
EndoStim Inc.
Conditions:
GERD
Sleeve Gastrectomy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- Subject is between 18 - 80 years of age.
- Subject underwent a sleeve gastrectomy minimum one year prior to enrollment (in order to have reached a stable weight loss plateau).
- Subject has a history of heartburn, regurgitation or both for \>6 month prompting physician recommendation of continual daily use of PPI after sleeve gastrectomy.
- Baseline off-PPI GERD-HRQL score ≥ 20 following 10-14 days off PPI
- Baseline off-PPI GERD-HRQLscore is at least 5 points higher than the on-PPI score or a positive relationship between the occurrence of their primary symptom during the pH impedance monitoring (symptom association probability ≥ 95% or a SI score ≥ 50%) is present.
- Subject who are on standard medical therapy for 6 months or longer and experience discomfort or who are otherwise dissatisfied with GERD symptoms.
- Subjects with a GERD condition that in the opinion of the PI justifies a minimally invasive reversible procedure prior to attempting a more drastic procedure such as a gastric bypass.
- Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry of antisecretory therapy performed within 6 months of screening visit; pH \< 4 for \> 6% of total time.
- Subject has a resting LES end expiratory pressure ≥ 5mmHg on manometry performed within 6 months of enrollment.
- Subject has no esophagitis or esophagitis ≤ Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
- Subject has esophageal body contraction amplitude \> 30 mmHg for \>30% of swallows and \> 30% peristaltic contractions on manometry.
- Subject has signed the informed consent form and is able to adhere to study visit schedule.
Exclusion
- Subject has any non-GERD esophageal motility disorders.
- Subject has evidence of obstruction or stricture in the gastric sleeve by a barium swallow and endoscopy.
- Subject has any significant multisystem diseases.
- 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.
- Subject has Barrett's epithelium (\> M2; \>C1) or any grade of dysplasia.
- Subject has a hiatal hernia larger than 3 cm.
- Subject has a body mass index (BMI) greater than 35 kg/m2.
- Subject has Type 1 Diabetes Mellitus
- Subject has uncontrolled Type 2 Diabetes Mellitus (T2DM) defined as HbA1c \>9.5 in the previous 6 months, or has T2DM for \> 10 years.
- Subject has a history of suspected or confirmed esophageal or gastric cancer.
- Subject has esophageal or gastric varices.
- Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
- Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
- Subject requires chronic anticoagulant therapy.
- Subject has dysphagia or esophageal peptic stricture, excluding Schatzki's ring.
- Subject of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
- Subject is currently enrolled in other potentially confounding research.
- History of any malignancy in the last 2 years.
- Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
- Weight change of +/- 10% of the EWL (Excess Weight Loss) in the 3 months prior to enrollment.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02210975
Start Date
July 1 2014
End Date
February 1 2016
Last Update
August 7 2014
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX