Gastroesophageal Reflux DiseasePhase 2NCT01578642
Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease
A Phase 2 study testing EndoStim LES Stimulation System in people with Gastroesophageal Reflux Disease, run by EndoStim Inc. at 1 site in Chile.
Trial summary
The EndoStim Stimulation System is an investigational device intended to improve the lower esophageal sphincter (LES) resting tone and restore LES function in individuals suffering with gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- EndoStim LES Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChile
- Study dates
- Sep 2010to May 2013
- Phase
- Phase 2
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between 21 - 65 years of age.
- Subject has a history of heartburn, regurgitation or both for > 6 months prompting physician recommendation of continual daily use of PPI before study entry.
- Baseline GERD-HRQL heartburn score of ≥ 20 off PPI assessed during the run-in phase.
- Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or II (or comparable local classification if any).
- Subject has demonstrated satisfactory symptomatic response to a previous course of GERD therapy (≥ 2 weeks); GERD HRQL heartburn score improvement of ≥ 10 on therapy as assessed during the run in phase.
- Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry off antisecretory therapy performed within 6 months of enrollment; pH < 4 for > 5% of total or > 3% of supine time.
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- 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 > 70% of swallows and > 50% peristaltic contractions on high resolution manometry.
- Subject has signed the informed consent form.
Who cannot join
- Subject has non-GERD esophageal motility disorders.
- Subject has gastroparesis.
- Subject has significant multisystem diseases.
- Subject has scleroderma requiring therapy in the preceding 2 years .
- Subject has dermatomyositis requiring therapy in the preceding 2 years.
- Subject has Calcinosis-Raynaud's-esophaguschlerodactyly syndrome requiring therapy in the preceding 2 years.
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- Subject has Sjogren's Syndrome requiring therapy in the preceding 2 years.
- Subject has Sharp's Syndrome requiring therapy in the preceding 2 years.
- Subject has persistent esophagitis greater than LA grade C.
- Subject has Barrett's epithelium (> M2; >C1) or any dysplasia.
- Subject has a hiatus hernia larger than 3 cm.
- Subject has a body mass Index 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 an autoimmune disorder requiring therapy in the preceding 2 years.
- Subject has 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).
- Subject requires chronic anticoagulant therapy.
- Subject has dysphagia or esophageal peptic structure, excluding Schatzki's ring.
- Subject is pregnant or intends to become pregnant during the trial period.
- Subject is currently enrolled in other potentially confounding research.
- Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
- History of any malignancy in the last 2 years
- History of previous esophageal or gastric surgery, including nissen fundoplication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study: An Evaluation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD)
The EndoStim Stimulation System is an investigational device intended to improve the lower esophageal sphincter (LES) resting tone and restore LES function in individuals suffering with gastroesophageal reflux disease (GERD).
Read the detailed description
EndoStim is developing an investigational medical device specifically designed to deliver electrical stimulation to the LES and has completed two clinical feasibility studies using the EndoStim stimulation system in fifteen subjects.
Acute electrical stimulation resulted in significant LES pressure with no adverse effects reported.
Results of these studies are promising and warrant additional clinical study to evaluate the effectiveness of EndoStim stimulation system to treat GERD over time.
In this study, EndoStim proposes using a fully implantable system. Results of this study are expected to provide confirmation of safety of long-term LES stimulation and may provide long term clinical benefit for GERD patients.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- EndoStim LES Stimulation System
- Keywords
- GERD, LES Pressure, Electrical 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.
EndoStim LES Stimulation SystemDevice
The EndoStim LES Stimulation System comprises three components:
an electrical stimulation lead an implantable pulse generator (IPG) and an external programmer.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm open label | Other | EndoStim LES Stimulation System Receives: Device: EndoStim LES Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Safety will be assessed by incidence and severity of adverse events through 12-week (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device implant and completion of the Week 12 evaluation: (1) death, or (2) medical morbidity, including myocardial infarction, pneumonia, wound infection, or perforation requiring hospitalization.
Measured: 3 months
Primary Endpoint: Functionality
Functionality of the EndoStim system will be assessed by the ability of the device to initiate stimulation as programmed and to accurately detect the patient's posture. Indication of device detection when the patient is lying horizontally and when standing up will be recorded.
Measured: Up to 3 months
Secondary outcomes (4)
GERD-HRQL
Improvement in GERD-HRQL with LES stimulation at the 12-weeks (3 months) follow-up compared to baseline
Measured: 3 months
GERD Symptoms
Changes in GERD symptoms as measured by the patient daily symptom-diary as well as the impact of GERD symptoms on quality of life as measured by SF-12 will be compared between baseline assessments and post-implant measures at 12 weeks (3 months).
Measured: 3 months
Lower Esophageal Measures
The baseline LES end expiratory pressure and the on-stimulation LES end expiratory pressure at 3 months
Measured: 3 months
Esophageal Acid Exposure
Total fractional esophageal acid exposure time with pH < 4.0. The data on baseline esophageal acid exposure off-therapy, prior to surgical implant of the stimulator and on-stimulation at 12 weeks (3 months) post-implant
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startSep 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoStim Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonardo RODRIGUEZ, M.D, Principal investigator, INDISA Clínica da Familia, Santiago, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578642
- Sponsor's protocol ID
- CS004
- Status last verified
- Jan 2013
- First submitted
- 11 Apr 2012
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez L, Rodriguez P, Gomez B, Ayala JC, Oxenberg D, Perez-Castilla A, Netto MG, Soffer E, Boscardin WJ, Crowell MD. Two-year results of intermittent electrical stimulation of the lower esophageal sphincter treatment of gastroesophageal reflux disease. Surgery. 2015 Mar;157(3):556-67. doi: 10.1016/j.surg.2014.10.012. Epub 2014 Nov 6.
PubMed 25726315
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study: An Evaluation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT01578642
- Acronym / sponsor ID
- CS004
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, LES Pressure, Electrical Stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- EndoStim Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 17 Apr 2012 (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 EndoStim Stimulation System is an investigational device intended to improve the lower esophageal sphincter (LES) resting tone and restore LES function in individuals suffering with gastroesophageal reflux disease (GERD).
Detailed description
EndoStim is developing an investigational medical device specifically designed to deliver electrical stimulation to the LES and has completed two clinical feasibility studies using the EndoStim stimulation system in fifteen subjects.
Acute electrical stimulation resulted in significant LES pressure with no adverse effects reported.
Results of these studies are promising and warrant additional clinical study to evaluate the effectiveness of EndoStim stimulation system to treat GERD over time.
In this study, EndoStim proposes using a fully implantable system. Results of this study are expected to provide confirmation of safety of long-term LES stimulation and may provide long term clinical benefit for GERD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm open label | Other | Device: EndoStim LES Stimulation SystemEndoStim LES Stimulation System |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is between 21 - 65 years of age.
- Subject has a history of heartburn, regurgitation or both for > 6 months prompting physician recommendation of continual daily use of PPI before study entry.
- Baseline GERD-HRQL heartburn score of ≥ 20 off PPI assessed during the run-in phase.
- Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or II (or comparable local classification if any).
- Subject has demonstrated satisfactory symptomatic response to a previous course of GERD therapy (≥ 2 weeks); GERD HRQL heartburn score improvement of ≥ 10 on therapy as assessed during the run in phase.
Key exclusion criteria (26 listed)
- Subject has non-GERD esophageal motility disorders.
- Subject has gastroparesis.
- Subject has significant multisystem diseases.
- Subject has scleroderma requiring therapy in the preceding 2 years .
- Subject has dermatomyositis requiring therapy in the preceding 2 years.
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 |
|---|---|---|
| EndoStim LES Stimulation SystemThe EndoStim LES Stimulation System comprises three components: an electrical stimulation lead an implantable pulse generator (IPG) and an external programmer. | Device | Single Arm open label |
Primary outcome
Primary Safety Endpoint
Time frame: 3 months
Safety will be assessed by incidence and severity of adverse events through 12-week (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device implant and completion of the Week 12 evaluation: (1) death, or (2) medical morbidity, including myocardial infarction, pneumonia, wound infection, or perforation requiring hospitalization.
Primary Endpoint: Functionality
Time frame: Up to 3 months
Functionality of the EndoStim system will be assessed by the ability of the device to initiate stimulation as programmed and to accurately detect the patient's posture. Indication of device detection when the patient is lying horizontally and when standing up will be recorded.
4 secondary outcomes
GERD-HRQL
Time frame: 3 months
GERD Symptoms
Time frame: 3 months
Lower Esophageal Measures
Time frame: 3 months
Esophageal Acid Exposure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Derived from this study: PubMed 25726315Rodriguez L, Rodriguez P, Gomez B, Ayala JC, Oxenberg D, Perez-Castilla A, Netto MG, Soffer E, Boscardin WJ, Crowell MD. Two-year results of intermittent electrical stimulation of the lower esophageal sphincter treatment of gastroesophageal reflux disease. Surgery. 2015 Mar;157(3):556-67. doi: 10.1016/j.surg.2014.10.012. Epub 2014 Nov 6.
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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.
Leonardo RODRIGUEZ, M.D principal investigator
INDISA Clínica da Familia, Santiago, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EndoStim LES Stimulation System in people with Gastroesophageal Reflux Disease, run by EndoStim Inc. at 1 site in Chile.
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 10 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: finished, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT01578642, which also lists 1 linked publication.
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 12 Feb 2014; AzTrials last refreshed its copy on 30 Oct 2026.