Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Therapeutic effect of electrical stimulation
a. Esophageal acid exposure
b. The baseline LES end expiratory pressure (LESPpre) and the on-stimulation
LES end expiratory pressure (LESPpost)
c. Acidity of the stomach
d. Effect of electrical stimulation on gastro-intestinal motility
Secondary outcome
(i) Side effects of electrical stimulation
(ii) Effect on quality of life
a. Change in patient*s GERD-HRQL, IGRQ and TACQOL
b. Change in symptoms frequency and severity
(iii) Effect of electrical stimulation on inflammatory and histologic
parameters.
a. Blood and breath samples
b. Endoscopy with biopsies
Background summary
Gastroesophageal Reflux Disease (GERD) is a problem affecting approximately
5-8% of children and adolescents worldwide. Neurologically impaired pediatric
patients are at high risk of developing serious complications such as
aspiration, reactive airway disease, acute life-threatening events, and failure
to thrive. Acid suppressive therapy is a safe and effective solution for many
patients but some are partially refractory to optimal drug therapy or suffer
from side effects. Nissen Fundoplication surgery is a common procedure for
patients who are unable to control GERD on medication alone; however the
prevalence of failure of Nissen fundoplication is much higher than in the adult
population and reaches almost 100 % of the cases. In addition, surgical therapy
while effective in decreasing GERD symptoms; suffers from high rate of
postoperative adverse events and the durability of the positive outcomes of the
procedure.
EndoStim LES stimulation system has been approved for adult with GERD. Results
from a chronic open-label study in adults suffering from GERD demonstrated that
the use of long-term electrical stimulation treatment can be effective in
reducing acid exposure and improving symptoms in GERD patients with follow up
of 48 months. EndoStim electrical stimulation therapy was shown to be safe and
well-tolerated, and resulted in a clinically significant and sustained
improvement in patient symptoms, end-expiratory and mean LES pressure,
esophageal acid exposure and esophagitis healing.
This study will further evaluate the efficacy of this procedure in the
pediatric population.
Study objective
Primary Objective:
Therapeutic effect of electrical stimulation.
Secondary Objective(s):
(i) Side effects of electrical stimulation
(ii) Effect on quality of life
(iii) Effect of electrical stimulation on inflammatory and histologic
parameters.
Study design
Prospective, multi-center open label treatment pilot trial.
Intervention
EndoStim LES Stimulation System.
Study burden and risks
Results from this study could validate a new, minimally invasive therapy for
the effective treatment of GERD in the pediatric population. If proven
effective, the therapy could provide the subject with improved LES function and
reduced symptoms of GERD and therefore reduce or eliminate the need for acid
suppressive therapy or other more invasive treatment. The invasive treatment is
surgery, whereby the anatomy of the patient is operatively changed. A normal
anatomy is maintained when using the EndoStim procedure.
The potential adverse events and risks associated with this study and the use
of the LES Stimulation System are identical to those normally associated with
standard gastrointestinal stimulation therapy or an invasive, clinical
procedure (e.g., IPG and electrode placement, etc.).
The following measurements will be additional and could be considered as a
burden:
* Screening: 24 hours gastric pH measurement, hydrogen breath test, exhaled
breath condensate, questionnaires and symptom diary.
* Implant: Endoscopy with biopsies
* 2 weeks post-operatively: blood samples, exhaled breath condensate,
questionnaires and symptom diary
* 3 months post-operatively: blood samples, exhaled breath condensate, 24 hours
gastric pH measurement, 24 hours esophageal pH and impedance measurement
(combined), manometry, hydrogen breath test, questionnaires and symptom diary.
* 6 months post-operatively: blood samples, exhaled breath condensate,
questionnaires and symptom diary.
Universiteitssingel 50
Maastricht 6200 MD
NL
Universiteitssingel 50
Maastricht 6200 MD
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56896.000.16 |