Gastroesophageal Reflux Disease (GERD)NCT02749071
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
A study testing Laparoscopic implantation surgery with or without crural repair, EndoStim stimulation for first six months of study and EndoStim stimulation from Month 6 thru end of study in people with Gastroesophageal Reflux Disease (GERD) and Reflux, Gastroesophageal, run by EndoStim Inc. at 21 sites in 4 countries.
Trial summary
The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal, Gastroesophageal Reflux
- What is being tested?
- Laparoscopic implantation surgery with or without crural repair, EndoStim stimulation for first six months of study and EndoStim stimulation from Month 6 thru end of study
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 21 sitesin 4 countries
- Study dates
- May 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent
- Able and willing to comply with required study procedures and follow-up schedule
- 22 - 75 years of age at the time of informed consent
- Documented symptoms of gastroesophageal reflux disease (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 anti-reflux drug therapy, who continue to have symptoms despite maximum medical therapy or are "intolerant" -severe side-effects (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.
- Symptomatic improvement on PPI therapy demonstrated by a composite GERD-health-related quality of life (HRQL) score of ≥20 off PPI, and a ≥10 point improvement on PPI compared to the off PPI composite GERD-HRQL score. Patients who meet the definition above of PPI intolerant are not required to have ≥10 point improvement. The on-PPI score to satisfy this criterion will be the score from the GERD-HRQL assessment completed after resuming PPIs following the Baseline visit.
- 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. At least 18 hour of esophageal pH recording will be considered adequate and inclusion will be based on the day (at least 18 hours of valid data) with the highest acid exposure percentage time.
Show all 9Show fewer
- Esophagitis ≤ Grade B (Los Angeles (LA) classification) as measured by upper endoscopy off PPI and H2 blockers for 10-14 days
- Esophageal body contraction amplitude > 30 mmHg for > 30% of swallows and > 30% peristaltic contractions on HRM or ≥ 30% peristaltic contractions with DCI >450.
- Suitable surgical candidate able to undergo general anesthesia and laparoscopic surgery
Who cannot join
- Previous EndoStim LES System implant and/or implant attempt
- Previous surgery involving the gastroesophageal junction or the lead implant site, such as a Nissen fundoplication
- Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
- Hiatal hernia larger than 3 cm as determined by endoscopy
- History of gastroparesis
- Any non-GERD esophageal motility disorders that in the opinion of investigator precludes an anti-reflux procedure
Show all 26Show fewer
- History of or known esophageal stricture or significant esophageal anatomic abnormalities (obstructive lesions, etc.)
- Barrett's esophagus or any grade of dysplasia
- Documented history of esophagitis Grade C or D (LA Classification)
- History of suspected or confirmed esophageal or gastric cancer
- Esophageal or gastric varices
- Symptoms of dysphagia more than once per week every week within the last 3 months
- Unable to tolerate withdrawal from H2 Blockers or PPI medications
- Suspected or known allergies to titanium, platinum, iridium, stainless steel, silicone, epoxy, or nylon
- Body mass index (BMI) > 35 kg/m2
- Any significant multisystem diseases
- Autoimmune or a connective tissue disorder (scleroderma, dermatomyositis, Calcinosis-Raynaud's-Esophagus Sclerodactyly Syndrome (CREST), Sjogren's Syndrome, Sharp's Syndrome, etc.) requiring therapy in the preceding 2 years
- 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
- 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.
- Significant cerebrovascular event within the last 6 months
- Existing implanted electrical stimulator (pacemaker, implantable cardioverter defibrillator, deep brain stimulator (DBS), bone growth or pelvic floor stimulators, drug pumps, etc.)
- Female subject of child-bearing 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
- Currently enrolled in other potentially confounding research
- Active infection as determined by the investigator
- History of any malignancy, other than basal cell carcinoma, in the last 2 years
- Life expectancy less than 3 years aa. Diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.) bb. 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
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States18 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Carolinas HealthCare System
Charlotte, North Carolina, 28260
The MetroHealth System
Cleveland, Ohio, 44109
The Ohio State University Medical Center
Columbus, Ohio, 43210
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, 80113
University of Southern California (USC)
Los Angeles, California, 90033
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Cornell University Weill Medical College
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15224
Oregon Clinic
Portland, Oregon, 97213
Oregon Health Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23298
Baylor Scott & White Research Institute
Round Rock, Texas, 78665
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Stanford Center for Clinical Research
Stanford, California, 94305
University of South Florida
Tampa, Florida, 33606
About this study
Official title: 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)
The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation.
Read the detailed description
The purpose of this investigation is to demonstrate the safety and effectiveness of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System in the treatment of subjects with gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled clinical investigation. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for a 6-month, double-blind phase followed by an additional open-label treatment phase in which all subjects will receive electrical stimulation therapy for a total of 12 months. Subjects continue on stimulation treatment and an extended open-label follow-up phase includes an 18 month post-stimulation phone interview followed by annual visits through 5 years post-stimulation.
- Conditions
- Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal, Gastroesophageal Reflux, Acid Reflux
- Being tested
- Laparoscopic implantation surgery with or without crural repair, EndoStim stimulation for first six months of study, EndoStim stimulation from Month 6 thru end of study, Sham EndoStim stimulation for first six months of study
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic implantation surgery with or without crural repairProcedure or surgery
Laparoscopic surgery with or without crural repair to implant the pulse generator and bipolar lead.
EndoStim stimulation for first six months of studyDevice
Also called EndoStim Implantable Pulse Generator (IPG), lower esophageal stimulation
Lower esophageal stimulation
EndoStim stimulation from Month 6 thru end of studyDevice
Also called EndoStim Implantable Pulse Generator (IPG), lower esophageal stimulation
Lower esophageal stimulation
Sham EndoStim stimulation for first six months of studyDevice
EndoStim device remains "off" (no stimulation delivered)
| Study group | Role | What they receive |
|---|---|---|
| Control Group (delayed stimulation) | Sham comparator | This group will undergo laparoscopic implantation surgery with or without crural repair (surgeon discretion). The device will not be activated: Sham EndoStim stimulation for first six months of study. It will be activated at the Month 6 visit and provide lower esophageal stimulation from Month 6 thru end of study. Receives: Procedure: Laparoscopic implantation surgery with or without crural repair; Device: EndoStim stimulation from Month 6 thru end of study; Device: Sham EndoStim stimulation for first six months of study |
| Treatment Group (immediate stimulation) | Experimental | The group will undergo laparoscopic implantation surgery with or without crural repair (surgeon discretion). The device will be activated two weeks post-implantation and the subject will receive EndoStim stimulation for first six months of study and continue with EndoStim stimulation from Month 6 thru end of study. Receives: Procedure: Laparoscopic implantation surgery with or without crural repair; Device: EndoStim stimulation for first six months of study; Device: EndoStim stimulation from Month 6 thru end of study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Rate of Device and/or Procedure-related Serious Adverse Events After 12 Months Post-implant
Rate of occurrence of device and/or procedure-related serious adverse events after 12 months of implant
Measured: 12 months after implant
Primary Efficacy Endpoint: Percentage of Subjects Achieving pH Success (pH<4 for More Than 5.3% of Time or at Least 50% Improvement in pH Compared to Baseline)
Comparison between treatment and control group: percentage of subjects achieving pH success ((pH<4 for more than 5.3% of time or at least 50% improvement in pH compared to baseline)
Measured: Comparison of 6 months to baseline data
Secondary outcomes (17)
Secondary Endpoint (Open-label, 12 Months on Stimulation): GERD-HRQL Score (Off-PPI/H2 Blocker)
The secondary efficacy endpoint was the number of subjects achieving GERD symptom success defined as an improvement in the composite GERD Health-related Quality of Life (GERD-HRQL) patient reported outcome questionnaire score of 50% or more after 12 months on stimulation compared to the baseline off-PPI or H2 blocker composite GERD-HRQL score. Questions regarding heartburn severity and difficulty swallowing are asked on scale of 0 to 5: 0 = No symptoms; 1 = Symptoms noticeable but not bothersome; 2 = Symptoms noticeable and bothersome but not every day; 3 = Symptoms bothersome every day; 4 = Symptoms affect daily activities; and 5 = Symptoms are incapacitating - unable to do activities. The composite score is calculated by adding the responses to the individual questions. The minimum score possible is 0 and the maximum score is 45.
Measured: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): GERD-HRQL On-PPI
Composite GERD Health-related Quality of Life (GERD-HRQL) patient reported outcome questionnaire scores. Questions regarding are asked on scale of 0 to 5: 0 = No symptoms; 1 = Symptoms noticeable but not bothersome; 2 = Symptoms noticeable and bothersome but not every day; 3 = Symptoms bothersome every day; 4 = Symptoms affect daily activities; and 5 = Symptoms are incapacitating - unable to do activities. The composite score is calculated by adding the responses to the individual questions. The minimum score possible is 0 and the maximum score is 45. Previous versions of the protocol and case report forms did not include the question about bloating; thus, this question was not included in the calculation of the composite score. The lower scores are associated with less impactful symptoms.
Measured: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Mean Percentage (%) of Time Distal Supine Esophageal pH is <4.0
Patients with a minimum of 18 hours of Bravo Esophageal pH monitoring had the percent time calculated for time where the distal supine esophageal pH < 4.0 over the total number of hours recorded. Data are reported as change from baseline.
Measured: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Severity of Heartburn Symptoms
Heartburn symptoms were recorded by the patient in a diary. Severity was scored on a scale of 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). Low scores represent a better outcome.
Median daily severity of worst episode during the on-PPI/H2 blocker period reported as change from baseline.
Measured: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Regurgitation Symptom Severity
Regurgitation symptoms were recorded by the patient in a diary. Severity was scored on a scale of 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). Low scores represent a better outcome.
Median daily severity of worst episode reported as change from baseline.
Measured: 12 months on stimulation
Secondary Endpoint (Open-label,12 Months on Stimulation): Stop Regular Use of Acid-suppression Medication
Number of subjects reporting more than 50% of days with no PPI medication use in the patient diary during the "on-PPI" period.
Measured: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): 50% or More Reduction in Nocturnal Symptoms of Heartburn
Heartburn symptoms were recorded by the patient in a diary. Severity was scored on a scale of 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe).
Percent of reported time with any heartburn symptoms at night during the on-PPI period.
Measured: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): 50% or More Reduction in Nocturnal Symptoms of Regurgitation
Regurgitation symptoms were recorded by the patient in a diary. Severity was scored on a scale of 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe).
Percent of reported time with any regurgitation symptoms at night during the on-PPI period. Data are reported as change from baseline.
Measured: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Quality of Life (SF-12) - Physical Health
The Short Form Health Survey (SF-12) is used to assess quality of life. Scores are generated from the Quality Metric proprietary algorithm. The mean score in the US general population is set to 50 with standard deviation of 10. The higher scores indicate a higher quality of life.
Number of patients with any improvement
Measured: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Quality of Life (SF-12) - Mental Health
The Short Form Health Survey (SF-12) was used to assess quality of life. Scores are generated from the Quality Metric proprietary algorithm. The mean score in the US general population is set to 50 with standard deviation of 10. The higher scores indicate a higher quality of life.
Number of patients with any improvement
Measured: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Stop All Use of Acid-suppression Medication
Number of subjects reporting zero days of PPI medication use in the patient diary during the "on-PPI" period.
Measured: 12 months on stimulation
Secondary Endpoint (Blinded): Regurgitation Symptom Frequency
As recorded in the patient diary (includes both day and night) for the on-PPI period. Data are reported as change from baseline of the percent of reported time with any regurgitation symptoms.
Measured: 6-month follow-up visit
Secondary Endpoint (Blinded): Bravo Esophageal pH Monitoring Fraction Time
Fraction of time (percent of total) with distal esophageal pH < 4.0 using Bravo Esophageal pH Monitoring from baseline to the Month 6 Visit for patients who were off PPI medication for a minimum of five days before the test. Data are reported as change from baseline.
Measured: 6-month visit
Secondary Endpoint (Blinded): Acid Suppression Medication Use
Percent of time reported in the patient diary with any PPI medication use for symptoms. Data are reported as change from baseline.
Measured: 6-month follow-up visit
Secondary Endpoint (Blinded): Heartburn Symptom Frequency
Heartburn symptom frequency (day and night) as measured by Subject Diary during the on-PPI period. Data are reported as change from baseline of the percent of reported time with any heartburn symptoms.
Measured: 6-month follow-up visit
Secondary Endpoint (Blinded): Quality of Life (SF-12) - Mental Health
The Short Form Health Survey (SF-12) was used to assess quality of life, both in terms of physical health and mental health. Scores are generated from the Quality Metric's proprietary algorithm. The mean score in the US general population is set to 50 with standard deviation of 10. The higher scores indicate a higher quality of life. Data are reported as change from baseline.
Measured: 6-month follow-up visit
Secondary Endpoint (Blinded): Quality of Life (SF-12) - Physical Heath Score
The Short Form Health Survey (SF-12) was used to assess quality of life, both in terms of physical health and mental health. Scores are generated from the Quality Metric's proprietary algorithm. The mean score in the US general population is set to 50 with standard deviation of 10. Higher scores indicate a higher quality of life. Data are reported as change from baseline.
Measured: 6-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: Met stopping rule per Bayesian analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoStim Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas J Shaheen, MD, MPH, Principal investigator, University of North CarolinaVic Velanovich, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749071
- Sponsor's protocol ID
- CS-100
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2016
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02749071
- Acronym / sponsor ID
- CS-100
- Conditions
- Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal, Gastroesophageal Reflux, Acid Reflux
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Met stopping rule per Bayesian analysis
- Enrolment
- 161 participants (actual)
- Lead sponsor
- EndoStim Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Posted 22 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation.
Detailed description
The purpose of this investigation is to demonstrate the safety and effectiveness of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System in the treatment of subjects with gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled clinical investigation. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for a 6-month, double-blind phase followed by an additional open-label treatment phase in which all subjects will receive electrical stimulation therapy for a total of 12 months. Subjects continue on stimulation treatment and an extended open-label follow-up phase includes an 18 month post-stimulation phone interview followed by annual visits through 5 years post-stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (delayed stimulation) | Sham comparator | Procedure: Laparoscopic implantation surgery with or without crural repair, Device: EndoStim stimulation from Month 6 thru end of study, Device: Sham EndoStim stimulation for first six months of studyThis group will undergo laparoscopic implantation surgery with or without crural repair (surgeon discretion). The device will not be activated: Sham EndoStim stimulation for first six months of study. It will be activated at the Month 6 visit and provide lower esophageal stimulation from Month 6 thru end of study. |
| Treatment Group (immediate stimulation) | Experimental | Procedure: Laparoscopic implantation surgery with or without crural repair, Device: EndoStim stimulation for first six months of study, Device: EndoStim stimulation from Month 6 thru end of studyThe group will undergo laparoscopic implantation surgery with or without crural repair (surgeon discretion). The device will be activated two weeks post-implantation and the subject will receive EndoStim stimulation for first six months of study and continue with EndoStim stimulation from Month 6 thru end of study. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able and willing to provide written informed consent
- Able and willing to comply with required study procedures and follow-up schedule
- 22 - 75 years of age at the time of informed consent
- Documented symptoms of gastroesophageal reflux disease (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 anti-reflux drug therapy, who continue to have symptoms despite maximum medical therapy or are "intolerant" -severe side-effects (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.
- Symptomatic improvement on PPI therapy demonstrated by a composite GERD-health-related quality of life (HRQL) score of ≥20 off PPI, and a ≥10 point improvement on PPI compared to the off PPI composite GERD-HRQL score. Patients who meet the definition above of PPI intolerant are not required to have ≥10 point improvement. The on-PPI score to satisfy this criterion will be the score from the GERD-HRQL assessment completed after resuming PPIs following the Baseline visit.
Key exclusion criteria (26 listed)
- Previous EndoStim LES System implant and/or implant attempt
- Previous surgery involving the gastroesophageal junction or the lead implant site, such as a Nissen fundoplication
- Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
- Hiatal hernia larger than 3 cm as determined by endoscopy
- History of gastroparesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic implantation surgery with or without crural repairLaparoscopic surgery with or without crural repair to implant the pulse generator and bipolar lead. | Procedure or surgery | Control Group (delayed stimulation), Treatment Group (immediate stimulation) |
| EndoStim stimulation for first six months of studyAlso: EndoStim Implantable Pulse Generator (IPG), lower esophageal stimulationLower esophageal stimulation | Device | Treatment Group (immediate stimulation) |
| EndoStim stimulation from Month 6 thru end of studyAlso: EndoStim Implantable Pulse Generator (IPG), lower esophageal stimulationLower esophageal stimulation | Device | Control Group (delayed stimulation), Treatment Group (immediate stimulation) |
| Sham EndoStim stimulation for first six months of studyEndoStim device remains "off" (no stimulation delivered) | Device | Control Group (delayed stimulation) |
Primary outcome
Primary Safety Endpoint: Rate of Device and/or Procedure-related Serious Adverse Events After 12 Months Post-implant
Time frame: 12 months after implant
Rate of occurrence of device and/or procedure-related serious adverse events after 12 months of implant
Primary Efficacy Endpoint: Percentage of Subjects Achieving pH Success (pH<4 for More Than 5.3% of Time or at Least 50% Improvement in pH Compared to Baseline)
Time frame: Comparison of 6 months to baseline data
Comparison between treatment and control group: percentage of subjects achieving pH success ((pH<4 for more than 5.3% of time or at least 50% improvement in pH compared to baseline)
17 secondary outcomes
Secondary Endpoint (Open-label, 12 Months on Stimulation): GERD-HRQL Score (Off-PPI/H2 Blocker)
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): GERD-HRQL On-PPI
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Mean Percentage (%) of Time Distal Supine Esophageal pH is <4.0
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Severity of Heartburn Symptoms
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Regurgitation Symptom Severity
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label,12 Months on Stimulation): Stop Regular Use of Acid-suppression Medication
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): 50% or More Reduction in Nocturnal Symptoms of Heartburn
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): 50% or More Reduction in Nocturnal Symptoms of Regurgitation
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Quality of Life (SF-12) - Physical Health
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Quality of Life (SF-12) - Mental Health
Time frame: 12 months on stimulation
Secondary Endpoint (Open-label, 12 Months on Stimulation): Stop All Use of Acid-suppression Medication
Time frame: 12 months on stimulation
Secondary Endpoint (Blinded): Regurgitation Symptom Frequency
Time frame: 6-month follow-up visit
Secondary Endpoint (Blinded): Bravo Esophageal pH Monitoring Fraction Time
Time frame: 6-month visit
Secondary Endpoint (Blinded): Acid Suppression Medication Use
Time frame: 6-month follow-up visit
Secondary Endpoint (Blinded): Heartburn Symptom Frequency
Time frame: 6-month follow-up visit
Secondary Endpoint (Blinded): Quality of Life (SF-12) - Mental Health
Time frame: 6-month follow-up visit
Secondary Endpoint (Blinded): Quality of Life (SF-12) - Physical Heath Score
Time frame: 6-month follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas J Shaheen, MD, MPH principal investigator
University of North Carolina
Vic Velanovich, MD principal investigator
University of South Florida
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic implantation surgery with or without crural repair, EndoStim stimulation for first six months of study and EndoStim stimulation from Month 6 thru end of study in people with Gastroesophageal Reflux Disease (GERD) and Reflux, Gastroesophageal, run by EndoStim Inc. at 21 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Belgium, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Rate of Device and/or Procedure-related Serious Adverse Events After 12 Months Post-implant (time frame: 12 months after implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.