Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD
NCT ID: NCT01574339
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2011-08-31
2016-12-31
Brief Summary
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Detailed Description
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This study will further evaluate the safety of the procedure and its feasibility for use in this group of patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
EndoStim LES Stimulation System
EndoStim LES Stimulation System
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.
Interventions
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EndoStim LES Stimulation System
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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.
Exclusion Criteria
* 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.
* 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.
21 Years
70 Years
ALL
No
Sponsors
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EndoStim Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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A. J. Bredenoord, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
T. Horbach, PD. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Stadtkrankenhaus Schwabach, Schwabach, Germany
A. Escalona, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago, Chile
Nageshwar Reddy, M.D.,
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology
Locations
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Hospital Clinico de la Pontificia Universidad Catolica de Chile
Santiago, , Chile
San Ignacio
Bogotá, , Colombia
Chinese University of Hong Kong (CUHK) / Prince of Whales
Hong Kong, , Hong Kong
Asian Institute of Gastroenterology
Hyderabad, , India
. Zalvador Zubiran National Institute of Medical Science and Nutrition
Mexico City, , Mexico
AMC Amsterdam
Amsterdam, , Netherlands
UMC Maastrcht
Maastricht, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
North Shore Hospital
Auckland, Takapuna, New Zealand
St. Thomas Hospital
London, , United Kingdom
Countries
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References
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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.
Sanmiguel 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.
Kappelle 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.
Other Identifiers
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CS005
Identifier Type: -
Identifier Source: org_study_id
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