NCT02210975

Brief Summary

Sleeve gastrectomy (SG) has gained popularity as both a staged and a definitive procedure for morbid obesity due to its technical simplicity, low-morbidity and excellent results both for weight loss and control of metabolic syndrome. There are however reports of SG worsening pre-existing GERD or causing new-onset GERD. Because of this, patients with pre-existing GERD have been denied the benefits of SG. In addition, patients that develop post-op GERD cannot undergo traditional anti-reflux surgery since the gastric fundus that is required for fundoplication is removed during the SG. Hence, patients with post-SG GERD not adequately controlled with medication can only opt for the more invasive gastric bypass procedure as their only surgical treatment option. In a recently reported case study, an obese patient with severe GERD successfully treated with EndoStim underwent SG and maintained adequate GERD control with continued use of LES stimulation therapy. However electrical stimulation was not yet tested systematically in patients with prior gastric operation such as sleeve gastrectomy. This study will test the hypothesis that electrical stimulation is effective in control of GERD associated with SG.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

1.5 years

First QC Date

August 4, 2014

Last Update Submit

August 6, 2014

Conditions

GERDSleeve Gastrectomy

Keywords

GERDLESSleeve GastrectomyElectrical Stimulation Therapy

Outcome Measures

Primary Outcomes (2)

  • The incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period.

    up to 12 month follow-up

  • Efficacy - Disease specific quality of life

    The change in patient's GERD-HRQL, where applicable, from baseline (as measured while off PPI) .

    Baseline, 6 and 12 month follow up

Secondary Outcomes (4)

  • pH-monitoring

    Baseline, 6 and 12 month FU

  • Questionnairres, symptom diary

    baseline, 6 and 12 month FU

  • Anti-secretory medication use

    Baseline, 6 and 12 month FU

  • HR-manometry

    Baseline, 6 and 12 month FU

Study Arms (1)

Electrical Stimulation Therapy

EXPERIMENTAL
Device: LES-Stimulation Device

Interventions

LES-Stimulation DeviceDEVICE
Also known as: EndoStim b.v.
Electrical Stimulation Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is between 18 - 80 years of age.
  • Subject underwent a sleeve gastrectomy minimum one year prior to enrollment (in order to have reached a stable weight loss plateau).
  • Subject has a history of heartburn, regurgitation or both for \>6 month prompting physician recommendation of continual daily use of PPI after sleeve gastrectomy.
  • Baseline off-PPI GERD-HRQL score ≥ 20 following 10-14 days off PPI
  • Baseline off-PPI GERD-HRQLscore is at least 5 points higher than the on-PPI score or a positive relationship between the occurrence of their primary symptom during the pH impedance monitoring (symptom association probability ≥ 95% or a SI score ≥ 50%) is present.
  • Subject who are on standard medical therapy for 6 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 a more drastic procedure such as a gastric bypass.
  • Subject has exhibited excessive lower esophageal acid exposure during 24-hour pH-metry of antisecretory therapy performed within 6 months of screening visit; pH \< 4 for \> 6% of total time.
  • Subject has a resting LES end expiratory pressure ≥ 5mmHg on manometry performed within 6 months of enrollment.
  • Subject has no esophagitis or esophagitis ≤ Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
  • Subject has esophageal body contraction amplitude \> 30 mmHg for \>30% of swallows and \> 30% peristaltic contractions on manometry.
  • Subject has signed the informed consent form and is able to adhere to study visit schedule.

You may not qualify if:

  • Subject has any non-GERD esophageal motility disorders.
  • Subject has evidence of obstruction or stricture in the gastric sleeve by a barium swallow and endoscopy.
  • Subject has any significant multisystem diseases.
  • Subject has an autoimmune or a connective tissue disorder (e.g. scleroderma, dematomyositis, 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Nicolaas F Rinsma, MD

CONTACT

+31433884190n.rinsma@maastrichtuniversity.nl

Selwyn van Rijn, MD

CONTACT

+3143375021selwyn.van.rijn@mumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 7, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations

NL(1)