NCT02514616

Brief Summary

The investigational device that will be used in this trial is the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System. The purpose of this trial is to evaluate the safety and the effectiveness of electrical stimulation therapy (EST) on the lower esophageal sphincter (LES) in the treatment of subjects with gastroesophageal reflux disease (GERD). The study population will consist of subjects diagnosed with pathological GERD as defined by abnormal pH and who complain of heartburn, regurgitation or both for \> 6 months, on a daily PPI use.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

July 24, 2015

Last Update Submit

November 19, 2015

Conditions

GERD

Keywords

RefluxReflux diseaseGastroesophageal reflux diseaseLower esophageal sphincter stimulation

Outcome Measures

Primary Outcomes (1)

  • Efficacy of EST on GERD symptoms (mean improvement in the GERD- health-related quality of life (HRQL) scores from baseline in control and treatment groups)

    Comparison between Treatment and Control Groups of the mean improvement in the composite GERD-HRQL scores from baseline measured after at least 14 days off proton pump inhibitors (PPIs)

    14 weeks

Secondary Outcomes (18)

  • Safety (Rate of occurrence of device- and procedure-related adverse events)

    12 months

  • Number of subjects achieving GERD symptom success

    12 months

  • Reflux symptoms measured by GERD-HRQL score

    6 months

  • Reflux symptoms measured by GERD-HRQL score

    12 months

  • Number of subjects able to stop regular use of acid-suppression

    12 months

  • +13 more secondary outcomes

Study Arms (2)

Active Electric Stimulation Therapy

ACTIVE COMPARATOR

The subject receives Active Electric Stimulation Therapy for 12 weeks, 2 weeks after laparoscopic IPG and lead implant procedure. The subject and physician will be blinded to the randomization group assignment. The subject continues on stimulation treatment after 14 weeks and an extended open-label follow-up phase includes annual visits through 5 years.

Procedure: Laparoscopic IPG and lead implant procedureDevice: Active Electric Stimulation Therapy

Delayed Electric Stimulation Therapy

SHAM COMPARATOR

The subject receives no active Electric Stimulation Therapy for 12 weeks, 2 weeks after laparoscopic IPG and lead implant procedure. The subject and physician will be blinded to the randomization group assignment. The subject will receive Active Electric Stimulation Therapy at week 14 visit, and an extended open-label follow-up phase includes annual visits through 5 years.

Procedure: Laparoscopic IPG and lead implant procedureDevice: Delayed Electric Stimulation Therapy

Interventions

Laparoscopic IPG and lead implant procedurePROCEDURE

EST placement

Also known as: EndoStim
Active Electric Stimulation TherapyDelayed Electric Stimulation Therapy
Active Electric Stimulation TherapyDEVICE

Device programming by the technician to deliver the EST system active (Treatment group) or no stimulation (Control group) for the following 12 weeks, at the 2 weeks visit.

Also known as: EndoStim
Active Electric Stimulation Therapy
Delayed Electric Stimulation TherapyDEVICE

Device programming by the technician to deliver the EST system no stimulation for the following 12 weeks at the 2 weeks visit. Active Electric Stimulation Therapy will be programmed at the 14 weeks visit.

Also known as: EndoStim
Delayed Electric Stimulation Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject able and willing to provide written informed consent
  • Subject able and willing to comply with required study procedures and follow-up schedule
  • Typical symptoms of GERD (regurgitation and/or heartburn) for longer than 6 months, heartburn responding to PPI therapy. Subject may also complain of atypical symptoms of GERD that may persist on PPI
  • Daily dose of PPI or other acid neutralization drugs because of PPI intolerance
  • Baseline visit GERD-HRQL score ≥ 20 following 14 days off-PPI and at least 10 points higher than their on-PPI (or other acid-neutralization drugs) GERD-HRQL score recorded during the Screening Visit
  • Excessive lower esophageal acid exposure during pH monitoring (defined as distal esophageal pH \< 4 for \> 5.0% of the monitoring time) performed after 14 days off PPIs
  • Subject is a suitable surgical candidate able to undergo general anesthesia and laparoscopic surgery.

You may not qualify if:

  • Previous EndoStim LES System implant and/or implant attempt
  • Previous esophageal surgery, including Nissen fundoplication
  • Previous endoscopic intervention for the treatment of GERD and/or Barrett's esophagus
  • Hiatal hernia larger than 2 cm as determined by any diagnostic investigation (i.e., endoscopy, manometry or laparoscopic visualization)
  • Gastroparesis
  • Any non-GERD esophageal motility disorders
  • Esophageal stricture or significant esophageal anatomic abnormalities
  • Barrett's epithelium or any grade of dysplasia
  • Documented history of esophagitis Grade C or D (LA Classification)
  • History of suspected or confirmed esophageal or gastric cancer
  • Esophageal or gastric varices
  • Symptoms of dysphagia more than once per week within the last 3 months
  • Suspected or known allergies to titanium, platinum, iridium, stainless steel, silicone, epoxy, or nylon
  • Body mass index (BMI) \> 35 kg/m2
  • Any significant multisystem diseases
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gastroenterology Department, Erasme University Hospital

Brussels, 1070, Belgium

Location

Hôpital Edouard Herriot, Service d'Explorations Fonctionnelles Digestives, Pavillons H et L, 5 Place d'Arsonval

Lyon, Lyon Cedex 3, 69437, France

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hubert LOUIS, pHD

Study Record Dates

First Submitted

July 24, 2015

First Posted

August 4, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

FR(1)BE(1)