Gastroesophageal Reflux DiseaseNCT01574339
Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD
A study testing EndoStim LES Stimulation System in people with Gastroesophageal Reflux Disease, run by EndoStim Inc. at 10 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 70 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
- 42 participants
- Where
- 10 sitesin 8 countries
- Study dates
- Aug 2011to Dec 2016
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
Netherlands3 sites
AMC Amsterdam
Amsterdam, 1105
UMC Maastrcht
Maastricht
UMC Utrecht
Utrecht, 3508
Chile1 site
Hospital Clinico de la Pontificia Universidad Catolica de Chile
Santiago
Hong Kong1 site
Chinese University of Hong Kong (CUHK) / Prince of Whales
Hong Kong
Mexico1 site
. Zalvador Zubiran National Institute of Medical Science and Nutrition
Mexico City
About this study
Official title: An Investigation 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 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).
Read the 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.
- 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 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.
Incidence and severity of adverse events
Safety will be assessed by incidence and severity of adverse events through 24 months of follow-up.
Measured: 24 months
Secondary outcomes (11)
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
- Noticeable, but not bothersome
- Noticeable, bothersome, but not every day
- Bothersome daily
- Bothersome and affects daily activities
- Incapacitating to do daily activities
Measured: 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
Measured: 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.
Measured: Changes in GERD symptoms as measured by the patient daily symptom-diary at 3, 6, 12, 18 and 24 months Vs. baseline.
Change in LES pressure
Change from baseline in LES baseline and expiratory pressure
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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:
- Absenteeism (work time missed)
- Presenteeism (impairment at work / reduced on-the-job effectiveness)
- Work productivity loss (overall work impairment / absenteeism plus presenteeism)
- Activity impairment It produces scores for each domain expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity
Measured: Baseline and 6, 12, and 24 months scores of Sleep quality and Work productivity questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled subjects will receive a functioning device and have stimulation delivered throughout the study.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoStim Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A. J. Bredenoord, Dr. med., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)T. Horbach, PD. Dr. med., Principal investigator, Stadtkrankenhaus Schwabach, Schwabach, GermanyA. Escalona, Dr. med., Principal investigator, Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago, ChileNageshwar Reddy, M.D.,, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574339
- Sponsor's protocol ID
- CS005
- Status last verified
- Feb 2025
- First submitted
- 22 Mar 2012
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sidhu AS, Triadafilopoulos G. Neuro-regulation of lower esophageal sphincter function as treatment for gastroesophageal reflux disease. World J Gastroenterol. 2008 Feb 21;14(7):985-90. doi: 10.3748/wjg.14.985.
PubMed 18286675Sanmiguel CP, Hagiike M, Mintchev MP, Cruz RD, Phillips EH, Cunneen SA, Conklin JL, Soffer EE. Effect of electrical stimulation of the LES on LES pressure in a canine model. Am J Physiol Gastrointest Liver Physiol. 2008 Aug;295(2):G389-94. doi: 10.1152/ajpgi.90201.2008.
PubMed 18687754Kappelle WF, Bredenoord AJ, Conchillo JM, Ruurda JP, Bouvy ND, van Berge Henegouwen MI, Chiu PW, Booth M, Hani A, Reddy DN, Bogte A, Smout AJ, Wu JC, Escalona A, Valdovinos MA, Torres-Villalobos G, Siersema PD. Electrical stimulation therapy of the lower oesophageal sphincter for refractory gastro-oesophageal reflux disease - interim results of an international multicentre trial. Aliment Pharmacol Ther. 2015 Sep;42(5):614-25. doi: 10.1111/apt.13306. Epub 2015 Jul 8.
PubMed 26153531
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation 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
- NCT01574339
- Acronym / sponsor ID
- CS005
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, LES Pressure, Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- EndoStim Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled subjects will receive a functioning device and have stimulation delivered throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: EndoStim LES Stimulation SystemEndoStim LES Stimulation System |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
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. 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. | Device | Treatment Arm |
Primary outcome
Incidence and severity of adverse events
Time frame: 24 months
Safety will be assessed by incidence and severity of adverse events through 24 months of follow-up.
11 secondary outcomes
Change in GERD-HRQL
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
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
Time frame: Changes in GERD symptoms as measured by the patient daily symptom-diary at 3, 6, 12, 18 and 24 months Vs. baseline.
Change in LES 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
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
Time frame: pH will be compared between baseline and 3, 6, 12 and 24 months.
Change in esophageal acid exposure
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
Time frame: Number of reflux events >5 minutes will be compared between baseline and 3, 6, 12 and 24 months.
Change in medication usage
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
Time frame: Baseline and 6, 12, and 24 months scores of Sleep quality questionnaire.
Change in work productivity
Time frame: Baseline and 6, 12, and 24 months scores of Sleep quality and Work productivity questionnaires
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 14 Feb 2025.
- Background: PubMed 18286675Sidhu AS, Triadafilopoulos G. Neuro-regulation of lower esophageal sphincter function as treatment for gastroesophageal reflux disease. World J Gastroenterol. 2008 Feb 21;14(7):985-90. doi: 10.3748/wjg.14.985.
- Background: PubMed 18687754Sanmiguel CP, Hagiike M, Mintchev MP, Cruz RD, Phillips EH, Cunneen SA, Conklin JL, Soffer EE. Effect of electrical stimulation of the LES on LES pressure in a canine model. Am J Physiol Gastrointest Liver Physiol. 2008 Aug;295(2):G389-94. doi: 10.1152/ajpgi.90201.2008.
- Derived from this study: PubMed 26153531Kappelle WF, Bredenoord AJ, Conchillo JM, Ruurda JP, Bouvy ND, van Berge Henegouwen MI, Chiu PW, Booth M, Hani A, Reddy DN, Bogte A, Smout AJ, Wu JC, Escalona A, Valdovinos MA, Torres-Villalobos G, Siersema PD. Electrical stimulation therapy of the lower oesophageal sphincter for refractory gastro-oesophageal reflux disease - interim results of an international multicentre trial. Aliment Pharmacol Ther. 2015 Sep;42(5):614-25. doi: 10.1111/apt.13306. Epub 2015 Jul 8.
- 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.
A. J. Bredenoord, Dr. med. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
T. Horbach, PD. Dr. med. principal investigator
Stadtkrankenhaus Schwabach, Schwabach, Germany
A. Escalona, Dr. med. principal investigator
Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago, Chile
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoStim LES Stimulation System in people with Gastroesophageal Reflux Disease, run by EndoStim Inc. at 10 sites in 8 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 11 inclusion and 20 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 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands, Chile, Colombia, Hong Kong, India and 3 more countries. 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.
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?
Incidence and severity of adverse events (time frame: 24 months). 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 NCT01574339, which also lists 3 linked publications.
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 14 Feb 2025.