Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Device: EndoStim LES Stimulation System
- Registration Number
- NCT01574339
- Lead Sponsor
- EndoStim Inc.
- Brief Summary
The EndoStim LES Stimulation System is an investigational device intended to improve the LES pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from Gastroesophageal Reflux Disease (GERD).
- Detailed Description
EndoStim has developed an investigational medical device specifically designed to deliver electrical stimulation to the LES and has completed two clinical feasibility studies using an external version of the EndoStim stimulation system in fifteen subjects. In these two short-term studies, electrical stimulation resulted in significant increases in LES pressure.
This study will further evaluate the safety of the procedure and its feasibility for use in this group of patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Subject is between 21 - 70 years of age.
- Subject has a history of heartburn, regurgitation or both for > 12 month prompting physician recommendation of continual daily use of PPI before study entry.
- Baseline GERD HRQL heartburn score following 10-14 days off PPI which is ≥ 20 and at least 10 points higher than the on PPI score
- Subject who are on standard medical therapy for 12 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 anatomical change such as Nissen fundoplication
- Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or II (or comparable local classification if any).
- Subject has exhibited excessive lower esophageal acid exposure during 24-hour pHmetry of antisecretory therapy performed within 6 months of screening visit; pH < 4 for > 5% of total time.
- Subject has a resting LES end expiratory pressure > 5mm Hg and < 15 mm Hg on a high resolution manometry within 6 months of enrollment.
- Subject has esophagitis ≤ Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
- Subject has esophageal body contraction amplitude > 30 mmHg for > 50% of swallows and > 50% peristaltic contractions on high resolution manometry.
- Subject has signed the informed consent form and is able to adhere to study visit schedule.
- Subject has any non-GERD esophageal motility disorders.
- Subject has gastroparesis.
- Subject has any significant multisystem diseases.
- Subject has an autoimmune or a connective tissue disorder (e.g. scleroderma, dermatomyositis, 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.
- History of previous esophageal or gastric surgery, including nissen fundoplication.
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm EndoStim LES Stimulation System -
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events 24 months Safety will be assessed by incidence and severity of adverse events through 24 months of follow-up.
- Secondary Outcome Measures
Name Time Method Change in GERD-HRQL Change in GERD-HRQL and RDQ questionnaire score when available from baseline (as measured off PPI) to 1, 3, 6, 12, 18 and 24 months. Heartburn and regurgitation scores will be calculated separately. Change from baseline in GERD-HRQL. The full title of this scale is GERD Health-Related Quality of Life (GERD-HRQL) Questionnaire. The scale is as follows, with the worst outcome scored as a 5:
0=No Symptoms
1. Noticeable, but not bothersome
2. Noticeable, bothersome, but not every day
3. Bothersome daily
4. Bothersome and affects daily activities
5. Incapacitating to do daily activitiesChange in GERD symptoms Changes in GERD symptoms as measured by the patient daily symptom-diary at 3, 6, 12, 18 and 24 months Vs. baseline. Change from baseline GERD symptoms measured by patient diary.
Change in LES pressure Baseline LES end expiratory pressure (LESPpre) will be compared with the end expiratory pressure (LESPpost) at 3 and 6 months. Change from baseline in LES baseline and expiratory pressure
Change in GI symptoms Symptoms will be compared between baseline (as measured while on and off PPI) to 1, 3, 6, 12, 18 and 24 months. Change from baseline in GI symptoms (while on and off PPI)
Change in esophageal acid exposure Number of reflux events >5 minutes will be compared between baseline and 3, 6, 12 and 24 months. Change in number of reflux events \> 5 minutes at baseline compared to 3, 6, 12 and 24 months.
Change in medication usage The use of antisecretory medication will be compared between baseline and 3, 6, 12, 18 and 24 months. Change from baseline in antisecretory medication use
Change in sleep-related quality of life Baseline and 6, 12, and 24 months scores of Sleep quality questionnaire. Change from baseline in Pittsburgh Sleep Quality Index (PSQI) scores. The full name of the scale Pittsburgh Sleep Quality Index (PSQI). It is a self-report questionnaire that assesses sleep quality over a one-month time interval. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Change in work productivity Baseline and 6, 12, and 24 months scores of Sleep quality and Work productivity questionnaires Change from baseline in Work Productivity and Activity Impairment Questionnaire scores. The Work Productivity and Activity Impairment (WPAI) Questionnaire is a 6-item instrument designed to measure impairments in work and activities over the past 7 days. It assesses four main domains:
1. Absenteeism (work time missed)
2. Presenteeism (impairment at work / reduced on-the-job effectiveness)
3. Work productivity loss (overall work impairment / absenteeism plus presenteeism)
4. Activity impairment It produces scores for each domain expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Trial Locations
- Locations (10)
Chinese University of Hong Kong (CUHK) / Prince of Whales
🇭🇰Hong Kong, Hong Kong
Hospital Clinico de la Pontificia Universidad Catolica de Chile
🇨🇱Santiago, Chile
San Ignacio
🇨🇴Bogota, Colombia
Asian Institute of Gastroenterology
🇮🇳Hyderabad, India
. Zalvador Zubiran National Institute of Medical Science and Nutrition
🇲🇽Mexico City, Mexico
AMC Amsterdam
🇳🇱Amsterdam, Netherlands
UMC Maastrcht
🇳🇱Maastricht, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
North Shore Hospital
🇳🇿Auckland, Takapuna, New Zealand
St. Thomas Hospital
🇬🇧London, United Kingdom