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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
The EndoStim LES Stimulation System comprises three components: an electrical stimulation lead, an implantable pulse generator (IPG) and an external programmer. The IPG and stimulation lead are to be implanted within the subject's body using conventional laparoscopy. The device programmer is to be used by the study investigator and/or a technical representative.
Hospital Clinico de la Pontificia Universidad Catolica de Chile
Santiago, Chile
San Ignacio
Bogotá, Colombia
Chinese University of Hong Kong (CUHK) / Prince of Whales
Hong Kong, Hong Kong
Asian Institute of Gastroenterology
Incidence and severity of adverse events
Safety will be assessed by incidence and severity of adverse events through 24 months of follow-up.
Time frame: 24 months
Change in GERD-HRQL
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 activities
Time frame: 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 in GERD symptoms
Changes in GERD symptoms measured by the SF-12 questionnaire at 6, 12, and 24 months compared to baseline. The full name of the scale is SF-12v2® PRO Health Survey which is a short-form patient-reported outcome (PRO) measurement that captures physical and mental well-being across eight health domains, for a variety of diseases, conditions, and treatment groups. It's made of two main summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). the practical ranges observed in a large U.S. general population are * PCS: 11.1 to 69.4 * MCS: 7.4 to 73.2 Higher scores on both PCS and MCS indicate better health
Time frame: Changes in GERD symptoms as measured by the SF-12 questionnaire will be compared between baseline assessments and post-implant measures at 6, 12, and 24 months.
Change in GERD symptoms
Change from baseline GERD symptoms measured by patient diary.
Time frame: Changes in GERD symptoms as measured by the patient daily symptom-diary at 3, 6, 12, 18 and 24 months Vs. baseline.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Change in LES pressure
Change from baseline in LES baseline and expiratory pressure
Time frame: Baseline LES end expiratory pressure (LESPpre) will be compared with the end expiratory pressure (LESPpost) at 3 and 6 months.
Change in GI symptoms
Change from baseline in GI symptoms (while on and off PPI)
Time frame: Symptoms will be compared between baseline (as measured while on and off PPI) to 1, 3, 6, 12, 18 and 24 months.
Change in esophageal acid exposure
Change in percent 24-hour esophageal pH \<4.0 at baseline compared to value at 3, 6, 12 and 24 months.
Time frame: pH will be compared between baseline and 3, 6, 12 and 24 months.
Change in esophageal acid exposure
Change in number of reflux events \> 1 minute at baseline compared to 3, 6, 12 and 24 months.
Time frame: Number of reflux events >1 minute will be compared between baseline and 3, 6, 12 and 24 months.
Change in esophageal acid exposure
Change in number of reflux events \> 5 minutes at baseline compared to 3, 6, 12 and 24 months.
Time frame: Number of reflux events >5 minutes will be compared between baseline and 3, 6, 12 and 24 months.
Change in medication usage
Change from baseline in antisecretory medication use
Time frame: The use of antisecretory medication will be compared between baseline and 3, 6, 12, 18 and 24 months.
Change in sleep-related quality of life
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.
Time frame: Baseline and 6, 12, and 24 months scores of Sleep quality questionnaire.
Change in work productivity
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
Time frame: Baseline and 6, 12, and 24 months scores of Sleep quality and Work productivity questionnaires