Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease

NCT01578642 | Completed Phase 2

• 1 other identifier: CS004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The EndoStim Stimulation System is an investigational device intended to improve the lower esophageal sphincter (LES) resting tone and restore LES function in individuals suffering with gastroesophageal reflux disease (GERD).

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD; LES Pressure; Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Safety will be assessed by incidence and severity of adverse events through 12-week (3 month) 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 Week 12 evaluation: (1) death, or (2) medical morbidity, including myocardial infarction, pneumonia, wound infection, or perforation requiring hospitalization.

  3 months

• Primary Endpoint: Functionality

  Functionality of the EndoStim system will be assessed by the ability of the device to initiate stimulation as programmed and to accurately detect the patient's posture. Indication of device detection when the patient is lying horizontally and when standing up will be recorded.

  Up to 3 months

Secondary Outcomes (4)

• GERD-HRQL

  3 months

• GERD Symptoms

  3 months

• Lower Esophageal Measures

  3 months

• Esophageal Acid Exposure

  3 months

Study Arms (1)

Single Arm open label

OTHER

EndoStim LES Stimulation System

Device: EndoStim LES Stimulation System

Interventions

EndoStim LES Stimulation System DEVICE

The EndoStim LES Stimulation System comprises three components: an electrical stimulation lead an implantable pulse generator (IPG) and an external programmer.

Single Arm open label

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 21 - 65 years of age.
• Subject has a history of heartburn, regurgitation or both for \> 6 months prompting physician recommendation of continual daily use of PPI before study entry.
• Baseline GERD-HRQL heartburn score of ≥ 20 off PPI assessed during the run-in phase.
• Subject has an American Society of Anesthesiologists (ASA) Physical Status Classification I or II (or comparable local classification if any).
• Subject has demonstrated satisfactory symptomatic response to a previous course of GERD therapy (≥ 2 weeks); GERD HRQL heartburn score improvement of ≥ 10 on therapy as assessed during the run in phase.
• Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry off antisecretory therapy performed within 6 months of enrollment; pH \< 4 for \> 5% of total or \> 3% of supine 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 \> 70% of swallows and \> 50% peristaltic contractions on high resolution manometry.
• Subject has signed the informed consent form.

You may not qualify if:

• Subject has non-GERD esophageal motility disorders.
• Subject has gastroparesis.
• Subject has significant multisystem diseases.
• Subject has scleroderma requiring therapy in the preceding 2 years .
• Subject has dermatomyositis requiring therapy in the preceding 2 years.
• Subject has Calcinosis-Raynaud's-esophaguschlerodactyly syndrome requiring therapy in the preceding 2 years.
• Subject has Sjogren's Syndrome requiring therapy in the preceding 2 years.
• Subject has Sharp's Syndrome requiring therapy in the preceding 2 years.
• Subject has persistent esophagitis greater than LA grade C.
• Subject has Barrett's epithelium (\> M2; \>C1) or any dysplasia.
• Subject has a hiatus hernia larger than 3 cm.
• Subject has a body mass Index 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 an autoimmune disorder requiring therapy in the preceding 2 years.

Sponsors & Collaborators

• EndoStim Inc.: lead

Study Sites (1)

INDISA Clínica da Familia

Santiago, Chile

Location

Related Publications (1)

• Rodriguez L, Rodriguez P, Gomez B, Ayala JC, Oxenberg D, Perez-Castilla A, Netto MG, Soffer E, Boscardin WJ, Crowell MD. Two-year results of intermittent electrical stimulation of the lower esophageal sphincter treatment of gastroesophageal reflux disease. Surgery. 2015 Mar;157(3):556-67. doi: 10.1016/j.surg.2014.10.012. Epub 2014 Nov 6.

  PMID: 25726315 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Leonardo RODRIGUEZ, M.D

  INDISA Clínica da Familia, Santiago, Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 17, 2012
• Study Start: September 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 12, 2014

Record last verified: 2013-01

Locations

CL (1)