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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01574339




Registration number
NCT01574339
Ethics application status
Date submitted
22/03/2012
Date registered
10/04/2012
Date last updated
18/03/2015

Titles & IDs
Public title
Effect of Long-Term Electrical Stimulation on LES Pressure and Esophageal Acid Exposure in Patients With GERD
Scientific title
An Investigation 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)
Secondary ID [1] 0 0
CS005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - EndoStim LES Stimulation System

Experimental: Treatment Arm -


Treatment: Devices: EndoStim LES Stimulation System
The EndoStim LES Stimulation System comprises three components: an electrical stimulation lead, an implantable pulse generator (IPG) and an external programmer.
The IPG and stimulation lead are to be implanted within the subject's body using conventional laparoscopy. The device programmer is to be used by the study investigator and/or a company technical representative.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Endpoint - Safety will be assessed by incidence and severity of adverse events through 6 months 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 month 6 evaluation: (1) death, or (2) medical morbidity associated with the device and/or implantation procedure.
Timepoint [1] 0 0
6 months follow-up
Secondary outcome [1] 0 0
Secondary Efficacy Endpoints - Change in patient's GERD-HRQL from baseline to 6 months.
Timepoint [1] 0 0
6 months follow-up
Secondary outcome [2] 0 0
Secondary Efficacy Endpoints - Baseline pH values of % 24-hour esophageal pH< 4.0, and number of reflux events >1minute and >5 minute duration with the same on-stimulation pH parameters at 6 months.
Timepoint [2] 0 0
6 months follow-up
Secondary outcome [3] 0 0
Secondary Efficacy Endpoints - Change in symptoms frequency and severity at 6 months Vs. baseline as measured by patient symptom diary and patients quality of life measured by SF- 12.
Timepoint [3] 0 0
6 months follow-up
Secondary outcome [4] 0 0
Secondary Efficacy Endpoints - Change in antisecretory medication use as evaluated during the two weeks prior to the month 6 follow up compared to baseline.
Timepoint [4] 0 0
6 months follow-up

Eligibility
Key inclusion criteria
- Subject is between 21 - 70 years of age.

- Subject has a history of heartburn, regurgitation or both for > 12 month prompting
physician recommendation of continual daily use of PPI before study entry.

- Baseline GERD HRQL heartburn score following 10-14 days off PPI which is = 20 and at
least 10 points higher than the on PPI score

- Subject who are on standard medical therapy for 12 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 anatomical change such as Nissen
fundoplication

- Subject has an American Society of Anesthesiologists (ASA) Physical Status
Classification I or II (or comparable local classification if any).

- Subject has exhibited excessive lower esophageal acid exposure during 24-hour pHmetry
of antisecretory therapy performed within 6 months of screening visit; pH < 4 for > 5%
of total 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 > 50% of swallows and
> 50% peristaltic contractions on high resolution manometry.

- Subject has signed the informed consent form and is able to adhere to study visit
schedule.
Minimum age
21 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has any non-GERD esophageal motility disorders.

- Subject has gastroparesis.

- Subject has any significant multisystem diseases.

- Subject has an autoimmune or a connective tissue disorder (e.g. scleroderma,
dermatomyositis, 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.

- Subject of child-bearing potential who is pregnant or intends to become pregnant
during the trial period.

- Subject is currently enrolled in other potentially confounding research.

- History of any malignancy in the last 2 years. History of previous esophageal or
gastric surgery, including nissen fundoplication.

- Subject has any condition that, at the discretion of the investigator or sponsor,
would preclude participation in the trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Santiago
Country [2] 0 0
Colombia
State/province [2] 0 0
Bogota
Country [3] 0 0
India
State/province [3] 0 0
Hyderabad
Country [4] 0 0
Mexico
State/province [4] 0 0
Mexico City
Country [5] 0 0
Netherlands
State/province [5] 0 0
Amsterdam
Country [6] 0 0
Netherlands
State/province [6] 0 0
Maastricht
Country [7] 0 0
Netherlands
State/province [7] 0 0
Utrecht
Country [8] 0 0
New Zealand
State/province [8] 0 0
Takapuna
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EndoStim Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The EndoStim LES Stimulation System is an investigational device intended to improve the LES
pressure and restore Lower Esophageal Sphincter (LES) function in individuals suffering from
Gastroesophageal Reflux Disease (GERD).
Trial website
https://clinicaltrials.gov/show/NCT01574339
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
A. J. Bredenoord, Dr. med.
Address 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01574339