An investigation of the Effect of Long-Term Electrical Stimulation on Esophageal Acid Exposure in Pediatric Patients with Gastroesophageal Reflux Disease (GERD)

Phase 2

Withdrawn

• Conditions: Heartburn; 10017943; Gastroesophageal Reflux Disease

• Registration Number: NL-OMON42836
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

a) Subject is between 5 * 16 years of age.
b) Subject has a history of heartburn, regurgitation or both for >6 month prompting physician recommendation of continual daily use of PPI before study entry.
c) Subject who are on standard medical therapy for 6 months or longer and experience discomfort or who are otherwise dissatisfied with GERD symptoms.
d) Subjects with a GERD condition that in the opinion of the PI justifies a minimally invasive reversible procedure prior to attempting anatomical change such as Nissen or Toupet fundoplication.
e) 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 > 5% of total time.
f) Subject has a resting LES end expiratory pressure * 5mmHg on manometry performed within 6 months of enrollment.
g) Subject has no esophagitis or esophagitis * Grade C (LA classification) on upper endoscopy within 6 months of enrollment.
h) Subject*s body weight >15kg.
i) Subject*s BMI <30 kg/m2.
j) Subject*s parent or legal guardian (and subject from age 12) has signed the informed consent form and is able to adhere to study visit schedule.

Exclusion Criteria

a) Subject has known non-GERD esophageal motility disorder that in the opinion of investigator precludes an anti-reflux procedure.
b) Subject has history of gastroparesis.
c) Subject has any history of significant multisystem diseases (e.g. kidney failure, liver failure).
d) Subject has a known 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.
e) Subject has Barrett*s epithelium (> M2; >C1) or any grade of dysplasia.
f) Subject has a hiatal hernia larger than 3 cm.
g) Subject has a body mass index (BMI) greater than 30 kg/m2.
h) Subject has Type 1 diabetes mellitus.
i) Subject has uncontrolled Type 2 diabetes mellitus (T2DM) defined as HbA1c >9.5 in the previous 6 months, or has T2DM for > 10 years.
j) Subject has a history of suspected or confirmed esophageal or gastric cancer.
k) Subject has esophageal or gastric varices.
l) Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
m) Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).
n) Subject requires chronic anticoagulant therapy.
o) Subject has dysphagia due to eosinophilic esophagitis, esophageal peptic stricture, excluding Schatzki*s ring.
p) Subject of child-bearing potential who is pregnant or intends to become pregnant during the trial period.
q) Subject is currently enrolled in other potentially confounding research.
r) History of any malignancy in the last 2 years.
s) History of previous surgery involving the LES, excluding Nissen and Toupet fundoplication.
t) Subject has any condition that, at the discretion of the investigator or sponsor, would preclude participation in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Therapeutic effect of electrical stimulation<br /><br>a. Esophageal acid exposure<br /><br>b. The baseline LES end expiratory pressure (LESPpre) and the on-stimulation<br /><br>LES end expiratory pressure (LESPpost)<br /><br>c. Acidity of the stomach<br /><br>d. Effect of electrical stimulation on gastro-intestinal motility</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(i) Side effects of electrical stimulation<br /><br><br /><br>(ii) Effect on quality of life<br /><br>a. Change in patient*s GERD-HRQL, IGRQ and TACQOL<br /><br>b. Change in symptoms frequency and severity<br /><br><br /><br>(iii) Effect of electrical stimulation on inflammatory and histologic<br /><br>parameters.<br /><br>a. Blood and breath samples<br /><br>b. Endoscopy with biopsies </p><br>