Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD
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|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
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease||Device: EndoStim LES Stimulation System||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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 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 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.
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
|Hospital Clinico de la Pontificia Universidad Catolica de Chile|
|Asian Institute of Gastroenterology|
|Hyderabad, India, 500082|
|. Zalvador Zubiran National Institute of Medical Science and Nutrition|
|Mexico City, Mexico|
|Amsterdam, Netherlands, 1105|
|Utrecht, Netherlands, 3508|
|North Shore Hospital|
|Aukland, Takapuna, New Zealand|
|St. Thomas Hospital|
|London, United Kingdom|
|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|