We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01574339
Recruitment Status : Unknown
Verified March 2015 by EndoStim Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 10, 2012
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
EndoStim Inc.

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date March 18, 2015
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2012)
Primary Safety Endpoint [ Time Frame: 6 months follow-up ]
Safety will be assessed by incidence and severity of adverse events through 6 months 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 month 6 evaluation: (1) death, or (2) medical morbidity associated with the device and/or implantation procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2012)
  • Secondary Efficacy Endpoints [ Time Frame: 6 months follow-up ]
    Change in patient's GERD-HRQL from baseline to 6 months.
  • Secondary Efficacy Endpoints [ Time Frame: 6 months follow-up ]
    Baseline pH values of % 24-hour esophageal pH< 4.0, and number of reflux events >1minute and >5 minute duration with the same on-stimulation pH parameters at 6 months.
  • Secondary Efficacy Endpoints [ Time Frame: 6 months follow-up ]
    Change in symptoms frequency and severity at 6 months Vs. baseline as measured by patient symptom diary and patients quality of life measured by SF- 12.
  • Secondary Efficacy Endpoints [ Time Frame: 6 months follow-up ]
    Change in antisecretory medication use as evaluated during the two weeks prior to the month 6 follow up compared to baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD
Official Title  ICMJE 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)
Brief 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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux Disease
Intervention  ICMJE Device: 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 company technical representative.

Study Arms  ICMJE Experimental: Treatment Arm
Intervention: Device: EndoStim LES Stimulation System
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 17, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2012)
Estimated Study Completion Date  ICMJE July 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).
  • 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 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Colombia,   India,   Mexico,   Netherlands,   New Zealand,   United Kingdom
Removed Location Countries Germany
Administrative Information
NCT Number  ICMJE NCT01574339
Other Study ID Numbers  ICMJE CS005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party EndoStim Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE EndoStim Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: A. J. Bredenoord, Dr. med. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: T. Horbach, PD. Dr. med. Stadtkrankenhaus Schwabach, Schwabach, Germany
Principal Investigator: A. Escalona, Dr. med. Hospital Clinico de la Pontificia Universidad Catolica de Chile, Santiago, Chile
Principal Investigator: Nageshwar Reddy, M.D., Asian Institute of Gastroenterology
PRS Account EndoStim Inc.
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP