GERDEST-SHAM-EURNCT02514616
Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (GERD)
A study testing Laparoscopic IPG and lead implant procedure, Active Electric Stimulation Therapy and Delayed Electric Stimulation Therapy in people with GERD, run by Erasme University Hospital at 2 sites in 2 countries.
Trial summary
The investigational device that will be used in this trial is the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System. The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of subjects with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GERD
- What is being tested?
- Laparoscopic IPG and lead implant procedure, Active Electric Stimulation Therapy and Delayed Electric Stimulation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject able and willing to provide written informed consent
- Subject able and willing to comply with required study procedures and follow-up schedule
- Typical symptoms of GERD (regurgitation and/or heartburn) for longer than 6 months, heartburn responding to PPI therapy. Subject may also complain of atypical symptoms of GERD that may persist on PPI
- Daily dose of PPI or other acid neutralization drugs because of PPI intolerance
- Baseline visit GERD-HRQL score ≥ 20 following 14 days off-PPI and at least 10 points higher than their on-PPI (or other acid-neutralization drugs) GERD-HRQL score recorded during the Screening Visit
- Excessive lower esophageal acid exposure during pH monitoring (defined as distal esophageal pH < 4 for > 5.0% of the monitoring time) performed after 14 days off PPIs
- Subject is a suitable surgical candidate able to undergo general anesthesia and laparoscopic surgery.
Who cannot join
- Previous EndoStim LES System implant and/or implant attempt
- Previous esophageal surgery, including Nissen fundoplication
- Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
- Hiatal hernia larger than 2 cm as determined by any diagnostic investigation (i.e., endoscopy, manometry or laparoscopic visualization)
- Gastroparesis
- Any non-GERD esophageal motility disorders
Show all 27Show fewer
- Esophageal stricture or significant esophageal anatomic abnormalities
- Barrett's epithelium 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 within the last 3 months
- 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, or has T2DM for > 10 years
- Significant cardiac arrhythmia or ectopy or significant cardiovascular disease (i.e. unstable angina pectoris, hemodynamically significant valvular disease, severe congestive heart failure), or 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.)
- Chronic anticoagulant therapy
- 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
- Subject is currently enrolled in other potentially confounding research
- Active infection as determined by the investigator
- History of any malignancy in the last 2 years
- Life expectancy less than 3 years
- Diagnosed major psychiatric disorder (bipolar, schizophrenia, etc.)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
Gastroenterology Department, Erasme University Hospital
Brussels, 1070
France1 site
Hôpital Edouard Herriot, Service d'Explorations Fonctionnelles Digestives, Pavillons H et L, 5 Place d'Arsonval
Lyon, Lyon Cedex 3, 69437
About this study
Official title: Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter: a Multicenter, Randomized, Double-blind, Sham-controlled Parallel-group Trial Evaluating Short Term Efficacy of EndoStim Device on GERD
The investigational device that will be used in this trial is the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System.
The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of subjects with gastroesophageal reflux disease (GERD).
The study population will consist of subjects diagnosed with pathological GERD as defined by abnormal pH and who complain of heartburn, regurgitation or both for > 6 months, on a daily PPI use.
Read the detailed description
Study Design:
Multicenter, randomized, double-blind, sham-controlled study. All subjects undergo screening and baseline visits, followed by system implantation, and randomization after 2 weeks to either a treatment Group (stimulation) or Control Group (delayed stimulation).
Randomized subjects complete a 10-week, double-blind phase. At the 14-week visit, subjects are unblinded, control group subjects begin receiving stimulation, and all subjects are followed for an additional 9-month open-label treatment phase.
Subjects continue receiving stimulation for an extended follow-up phase involving annual visits through 5 years.
Study Visits:
Screening and baseline visits. Laparoscopic implantable pulse generator (IPG) and lead implant procedure. Post-implant follow-up office visits at 2 weeks/randomization, 6, 10, 14, 24 and 48 weeks, followed by annual visits through 5 years.
Sample Size and Scope:
Forty-six subjects will be implanted and followed to 12 months after stimulation treatment at 3 investigational sites.
- Conditions
- GERD
- Being tested
- Laparoscopic IPG and lead implant procedure, Active Electric Stimulation Therapy, Delayed Electric Stimulation Therapy
- Keywords
- Reflux, Reflux disease, Gastroesophageal reflux disease, Lower esophageal sphincter stimulation
- 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 IPG and lead implant procedureProcedure or surgery
Also called EndoStim
EST placement
Active Electric Stimulation TherapyDevice
Also called EndoStim
Device programming by the technician to deliver the EST system active (Treatment group) or no stimulation (Control group) for the following 12 weeks, at the 2 weeks visit.
Delayed Electric Stimulation TherapyDevice
Also called EndoStim
Device programming by the technician to deliver the EST system no stimulation for the following 12 weeks at the 2 weeks visit. Active Electric Stimulation Therapy will be programmed at the 14 weeks visit.
| Study group | Role | What they receive |
|---|---|---|
| Active Electric Stimulation Therapy | Active comparator | The subject receives Active Electric Stimulation Therapy for 12 weeks, 2 weeks after laparoscopic IPG and lead implant procedure. The subject and physician will be blinded to the randomization group assignment. The subject continues on stimulation treatment after 14 weeks and an extended open-label follow-up phase includes annual visits through 5 years. Receives: Procedure: Laparoscopic IPG and lead implant procedure; Device: Active Electric Stimulation Therapy |
| Delayed Electric Stimulation Therapy | Sham comparator | The subject receives no active Electric Stimulation Therapy for 12 weeks, 2 weeks after laparoscopic IPG and lead implant procedure. The subject and physician will be blinded to the randomization group assignment. The subject will receive Active Electric Stimulation Therapy at week 14 visit, and an extended open-label follow-up phase includes annual visits through 5 years. Receives: Procedure: Laparoscopic IPG and lead implant procedure; Device: Delayed Electric Stimulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of EST on GERD symptoms (mean improvement in the GERD- health-related quality of life (HRQL) scores from baseline in control and treatment groups)
Comparison between Treatment and Control Groups of the mean improvement in the composite GERD-HRQL scores from baseline measured after at least 14 days off proton pump inhibitors (PPIs)
Measured: 14 weeks
Secondary outcomes (18)
Safety (Rate of occurrence of device- and procedure-related adverse events)
Measured: 12 months
Number of subjects achieving GERD symptom success
Improvement in the total GERD-HRQL score of 50% or more compared to pre-implantation score off PPI
Measured: 12 months
Reflux symptoms measured by GERD-HRQL score
Mean improvement in the composite GERD-HRQL scores from baseline measured after at least 14 days off proton pump inhibitors (PPIs)
Measured: 6 months
Reflux symptoms measured by GERD-HRQL score
Mean improvement in the composite GERD-HRQL scores from baseline measured after at least 14 days off proton pump inhibitors (PPIs)
Measured: 12 months
Number of subjects able to stop regular use of acid-suppression
Defined as 50% or more days without PPI use
Measured: 12 months
Number of subjects able to stop all use of acid-suppression medication
Measured: 12 months
Percentage of asymptomatic patients
Defined as an improvement in their total GERD-HRQL score of 50% or more compared to pre-implantation score off PPI) in treatment and control groups, off-PPI for the last 2 weeks.
Measured: 14 weeks
Incidence of reflux esophagitis
Measured: 12 months
Quality of life measured by EQ-5D EuroQol score
Difference in patient's EQ-5D score, compared to pre-implantation score on and off PPI.
Measured: 14 weeks
Quality of life measured by EQ-5D score
Difference in patient's EQ-5D score, compared to pre-implantation score on and off PPI.
Measured: 6 months
Quality of life measured by EQ-5D score
Difference in patient's EQ-5D score, compared to pre-implantation score on and off PPI.
Measured: 12 months
Efficacy of EST on acid reflux measured by esophageal pH
Difference in % 24 hour esophageal pH<4 in Treatment and Control groups (total, upright, supine, postprandial (2h)).
Measured: 14 weeks
Efficacy of EST on acid reflux measured by DeMeester score
Difference in DeMeester score in Treatment and Control groups.
Measured: 14 weeks
Percentage of subjects achieving pH success
Defined as normalization (pH < 4 for no more than 4.1% of monitoring time) or > 50% improvement in their distal esophageal acid exposure compared to their baseline off-PPI distal esophageal pH.
Measured: 14 weeks
Efficacy of EST on reflux episodes measured by esophageal impedance
Difference in the number of reflux episodes (total, upright, supine, postprandial (2h), acidic, weakly acidic, weakly alkaline, and proximal extent (15 cm) in Treatment and Control groups.
Measured: 14 weeks
Difference in lower esophageal sphincter (LOS) pressure and integrated relaxation pressure at 4 seconds (IRP4s) in Treatment and Control groups
Measured: 14 weeks
Comparison of GERD-HRQL scores in Treatment and Control groups
Measured: 14 weeks
Comparison of quality of life measured by EQ-5D in Treatment and Control groups
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Early termination due to a suspension of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- EndoStim Inc.
- Responsible party
- Principal investigator, Hubert Louis, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514616
- Sponsor's protocol ID
- ESE-001
- Acronym
- EST-SHAM-EUR
- Status last verified
- Nov 2015
- First submitted
- 24 Jul 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter: a Multicenter, Randomized, Double-blind, Sham-controlled Parallel-group Trial Evaluating Short Term Efficacy of EndoStim Device on GERD
- ClinicalTrials.gov ID
- NCT02514616
- Acronym / sponsor ID
- EST-SHAM-EUR / ESE-001
- Conditions
- GERD
- Keywords
- Reflux, Reflux disease, Gastroesophageal reflux disease, Lower esophageal sphincter stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to a suspension of financial support
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- EndoStim Inc.
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigational device that will be used in this trial is the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System.
The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of subjects with gastroesophageal reflux disease (GERD).
The study population will consist of subjects diagnosed with pathological GERD as defined by abnormal pH and who complain of heartburn, regurgitation or both for > 6 months, on a daily PPI use.
Detailed description
Study Design:
Multicenter, randomized, double-blind, sham-controlled study. All subjects undergo screening and baseline visits, followed by system implantation, and randomization after 2 weeks to either a treatment Group (stimulation) or Control Group (delayed stimulation).
Randomized subjects complete a 10-week, double-blind phase. At the 14-week visit, subjects are unblinded, control group subjects begin receiving stimulation, and all subjects are followed for an additional 9-month open-label treatment phase.
Subjects continue receiving stimulation for an extended follow-up phase involving annual visits through 5 years.
Study Visits:
Screening and baseline visits. Laparoscopic implantable pulse generator (IPG) and lead implant procedure. Post-implant follow-up office visits at 2 weeks/randomization, 6, 10, 14, 24 and 48 weeks, followed by annual visits through 5 years.
Sample Size and Scope:
Forty-six subjects will be implanted and followed to 12 months after stimulation treatment at 3 investigational sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Electric Stimulation Therapy | Active comparator | Procedure: Laparoscopic IPG and lead implant procedure, Device: Active Electric Stimulation TherapyThe subject receives Active Electric Stimulation Therapy for 12 weeks, 2 weeks after laparoscopic IPG and lead implant procedure. The subject and physician will be blinded to the randomization group assignment. The subject continues on stimulation treatment after 14 weeks and an extended open-label follow-up phase includes annual visits through 5 years. |
| Delayed Electric Stimulation Therapy | Sham comparator | Procedure: Laparoscopic IPG and lead implant procedure, Device: Delayed Electric Stimulation TherapyThe subject receives no active Electric Stimulation Therapy for 12 weeks, 2 weeks after laparoscopic IPG and lead implant procedure. The subject and physician will be blinded to the randomization group assignment. The subject will receive Active Electric Stimulation Therapy at week 14 visit, and an extended open-label follow-up phase includes annual visits through 5 years. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject able and willing to provide written informed consent
- Subject able and willing to comply with required study procedures and follow-up schedule
- Typical symptoms of GERD (regurgitation and/or heartburn) for longer than 6 months, heartburn responding to PPI therapy. Subject may also complain of atypical symptoms of GERD that may persist on PPI
- Daily dose of PPI or other acid neutralization drugs because of PPI intolerance
- Baseline visit GERD-HRQL score ≥ 20 following 14 days off-PPI and at least 10 points higher than their on-PPI (or other acid-neutralization drugs) GERD-HRQL score recorded during the Screening Visit
Key exclusion criteria (27 listed)
- Previous EndoStim LES System implant and/or implant attempt
- Previous esophageal surgery, including Nissen fundoplication
- Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
- Hiatal hernia larger than 2 cm as determined by any diagnostic investigation (i.e., endoscopy, manometry or laparoscopic visualization)
- 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 IPG and lead implant procedureAlso: EndoStimEST placement | Procedure or surgery | Active Electric Stimulation Therapy, Delayed Electric Stimulation Therapy |
| Active Electric Stimulation TherapyAlso: EndoStimDevice programming by the technician to deliver the EST system active (Treatment group) or no stimulation (Control group) for the following 12 weeks, at the 2 weeks visit. | Device | Active Electric Stimulation Therapy |
| Delayed Electric Stimulation TherapyAlso: EndoStimDevice programming by the technician to deliver the EST system no stimulation for the following 12 weeks at the 2 weeks visit. Active Electric Stimulation Therapy will be programmed at the 14 weeks visit. | Device | Delayed Electric Stimulation Therapy |
Primary outcome
Efficacy of EST on GERD symptoms (mean improvement in the GERD- health-related quality of life (HRQL) scores from baseline in control and treatment groups)
Time frame: 14 weeks
Comparison between Treatment and Control Groups of the mean improvement in the composite GERD-HRQL scores from baseline measured after at least 14 days off proton pump inhibitors (PPIs)
18 secondary outcomes
Safety (Rate of occurrence of device- and procedure-related adverse events)
Time frame: 12 months
Number of subjects achieving GERD symptom success
Time frame: 12 months
Reflux symptoms measured by GERD-HRQL score
Time frame: 6 months
Reflux symptoms measured by GERD-HRQL score
Time frame: 12 months
Number of subjects able to stop regular use of acid-suppression
Time frame: 12 months
Number of subjects able to stop all use of acid-suppression medication
Time frame: 12 months
Percentage of asymptomatic patients
Time frame: 14 weeks
Incidence of reflux esophagitis
Time frame: 12 months
Quality of life measured by EQ-5D EuroQol score
Time frame: 14 weeks
Quality of life measured by EQ-5D score
Time frame: 6 months
Quality of life measured by EQ-5D score
Time frame: 12 months
Efficacy of EST on acid reflux measured by esophageal pH
Time frame: 14 weeks
Efficacy of EST on acid reflux measured by DeMeester score
Time frame: 14 weeks
Percentage of subjects achieving pH success
Time frame: 14 weeks
Efficacy of EST on reflux episodes measured by esophageal impedance
Time frame: 14 weeks
Difference in lower esophageal sphincter (LOS) pressure and integrated relaxation pressure at 4 seconds (IRP4s) in Treatment and Control groups
Time frame: 14 weeks
Comparison of GERD-HRQL scores in Treatment and Control groups
Time frame: 14 weeks
Comparison of quality of life measured by EQ-5D in Treatment and Control groups
Time frame: 14 weeks
Results and safety
The study was stopped early (reason given: Early termination due to a suspension of financial support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic IPG and lead implant procedure, Active Electric Stimulation Therapy and Delayed Electric Stimulation Therapy in people with GERD, run by Erasme University Hospital at 2 sites in 2 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 7 inclusion and 27 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. 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?
The study was stopped early (reason given: Early termination due to a suspension of financial support). Results are not available in the source record.
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?
Efficacy of EST on GERD symptoms (mean improvement in the GERD- health-related quality of life (HRQL) scores from baseline in control and treatment groups) (time frame: 14 weeks). 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 20 Nov 2015.