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

Primary Purpose

Gastroesophageal Reflux Disease

Status

Completed

Phase

Phase 2

Locations

Chile

Study Type

Interventional

Intervention

EndoStim LES Stimulation System

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, LES Pressure, Electrical Stimulation

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Subject has 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).
Subject requires chronic anticoagulant therapy.
Subject has dysphagia or esophageal peptic structure, excluding Schatzki's ring.
Subject is pregnant or intends to become pregnant during the trial period.
Subject is currently enrolled in other potentially confounding research.
Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
History of any malignancy in the last 2 years
History of previous esophageal or gastric surgery, including nissen fundoplication

Sites / Locations

INDISA Clínica da Familia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm open label

Arm Description

EndoStim LES Stimulation System

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

GERD-HRQL

Improvement in GERD-HRQL with LES stimulation at the 12-weeks (3 months) follow-up compared to baseline

GERD Symptoms

Changes in GERD symptoms as measured by the patient daily symptom-diary as well as the impact of GERD symptoms on quality of life as measured by SF-12 will be compared between baseline assessments and post-implant measures at 12 weeks (3 months).

Lower Esophageal Measures

The baseline LES end expiratory pressure and the on-stimulation LES end expiratory pressure at 3 months

Esophageal Acid Exposure

Total fractional esophageal acid exposure time with pH < 4.0. The data on baseline esophageal acid exposure off-therapy, prior to surgical implant of the stimulator and on-stimulation at 12 weeks (3 months) post-implant

Full Information

NCT ID

NCT01578642

First Posted

April 11, 2012

Last Updated

February 11, 2014

Sponsor

EndoStim Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01578642

Brief Title

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

Official Title

A Feasibility Study: An Evaluation 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 Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EndoStim Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

EndoStim is developing an investigational medical device specifically designed to deliver electrical stimulation to the LES and has completed two clinical feasibility studies using the EndoStim stimulation system in fifteen subjects. Acute electrical stimulation resulted in significant LES pressure with no adverse effects reported. Results of these studies are promising and warrant additional clinical study to evaluate the effectiveness of EndoStim stimulation system to treat GERD over time. In this study, EndoStim proposes using a fully implantable system. Results of this study are expected to provide confirmation of safety of long-term LES stimulation and may provide long term clinical benefit for GERD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease

Keywords

GERD, LES Pressure, Electrical Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm open label

Arm Type

Other

Arm Description

EndoStim LES Stimulation System

Intervention Type

Device

Intervention Name(s)

EndoStim LES Stimulation System

Intervention Description

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

Primary Outcome Measure Information:

Title

Primary Safety Endpoint

Description

Time Frame

3 months

Title

Primary Endpoint: Functionality

Description

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

GERD-HRQL

Description

Improvement in GERD-HRQL with LES stimulation at the 12-weeks (3 months) follow-up compared to baseline

Time Frame

3 months

Title

GERD Symptoms

Description

Time Frame

3 months

Title

Lower Esophageal Measures

Description

The baseline LES end expiratory pressure and the on-stimulation LES end expiratory pressure at 3 months

Time Frame

3 months

Title

Esophageal Acid Exposure

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Subject has 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). Subject requires chronic anticoagulant therapy. Subject has dysphagia or esophageal peptic structure, excluding Schatzki's ring. Subject is pregnant or intends to become pregnant during the trial period. Subject is currently enrolled in other potentially confounding research. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial. History of any malignancy in the last 2 years History of previous esophageal or gastric surgery, including nissen fundoplication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leonardo RODRIGUEZ, M.D

Organizational Affiliation

INDISA Clínica da Familia, Santiago, Chile

Official's Role

Principal Investigator

Facility Information:

Facility Name

INDISA Clínica da Familia

City

Santiago

Country

Chile

12. IPD Sharing Statement

Citations:

PubMed Identifier

25726315

Citation

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.

Results Reference

derived

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

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