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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
Sponsor:
Information provided by (Responsible Party):
EndoStim Inc.

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).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Device: EndoStim LES Stimulation System Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : August 2011
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Treatment Arm 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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Secondary Efficacy Endpoints [ Time Frame: 6 months follow-up ]
    Change in patient's GERD-HRQL from baseline to 6 months.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574339


Locations
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Chile
Hospital Clinico de la Pontificia Universidad Catolica de Chile
Santiago, Chile
Colombia
San Ignacio
Bogota, Colombia
India
Asian Institute of Gastroenterology
Hyderabad, India, 500082
Mexico
. Zalvador Zubiran National Institute of Medical Science and Nutrition
Mexico City, Mexico
Netherlands
AMC Amsterdam
Amsterdam, Netherlands, 1105
UMC Maastrcht
Maastricht, Netherlands
UMC Utrecht
Utrecht, Netherlands, 3508
New Zealand
North Shore Hospital
Aukland, Takapuna, New Zealand
United Kingdom
St. Thomas Hospital
London, United Kingdom
Sponsors and Collaborators
EndoStim Inc.
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: EndoStim Inc.
ClinicalTrials.gov Identifier: NCT01574339    
Other Study ID Numbers: CS005
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015
Keywords provided by EndoStim Inc.:
GERD
LES Pressure
Electrical Stimulation
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases