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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01574339
Ethics application status
Date submitted
22/03/2012
Date registered
10/04/2012

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 - EndoStim LES Stimulation System


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

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Change in GERD-HRQL
Timepoint [1] 0 0
Change in GERD-HRQL and RDQ questionnaire score when available from baseline (as measured off PPI) to 1, 3, 6, 12, 18 and 24 months. Heartburn and regurgitation scores will be calculated separately.
Secondary outcome [2] 0 0
Change in GERD symptoms
Timepoint [2] 0 0
Changes in GERD symptoms as measured by the SF-12 questionnaire will be compared between baseline assessments and post-implant measures at 6, 12, and 24 months.
Secondary outcome [3] 0 0
Change in GERD symptoms
Timepoint [3] 0 0
Changes in GERD symptoms as measured by the patient daily symptom-diary at 3, 6, 12, 18 and 24 months Vs. baseline.
Secondary outcome [4] 0 0
Change in LES pressure
Timepoint [4] 0 0
Baseline LES end expiratory pressure (LESPpre) will be compared with the end expiratory pressure (LESPpost) at 3 and 6 months.
Secondary outcome [5] 0 0
Change in GI symptoms
Timepoint [5] 0 0
Symptoms will be compared between baseline (as measured while on and off PPI) to 1, 3, 6, 12, 18 and 24 months.
Secondary outcome [6] 0 0
Change in esophageal acid exposure
Timepoint [6] 0 0
pH will be compared between baseline and 3, 6, 12 and 24 months.
Secondary outcome [7] 0 0
Change in esophageal acid exposure
Timepoint [7] 0 0
Number of reflux events >1 minute will be compared between baseline and 3, 6, 12 and 24 months.
Secondary outcome [8] 0 0
Change in esophageal acid exposure
Timepoint [8] 0 0
Number of reflux events >5 minutes will be compared between baseline and 3, 6, 12 and 24 months.
Secondary outcome [9] 0 0
Change in medication usage
Timepoint [9] 0 0
The use of antisecretory medication will be compared between baseline and 3, 6, 12, 18 and 24 months.
Secondary outcome [10] 0 0
Change in sleep-related quality of life
Timepoint [10] 0 0
Baseline and 6, 12, and 24 months scores of Sleep quality questionnaire.
Secondary outcome [11] 0 0
Change in work productivity
Timepoint [11] 0 0
Baseline and 6, 12, and 24 months scores of Sleep quality and Work productivity questionnaires

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
Sex
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
Not applicable
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
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
42
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
Hong Kong
State/province [3] 0 0
Hong Kong
Country [4] 0 0
India
State/province [4] 0 0
Hyderabad
Country [5] 0 0
Mexico
State/province [5] 0 0
Mexico City
Country [6] 0 0
Netherlands
State/province [6] 0 0
Amsterdam
Country [7] 0 0
Netherlands
State/province [7] 0 0
Maastricht
Country [8] 0 0
Netherlands
State/province [8] 0 0
Utrecht
Country [9] 0 0
New Zealand
State/province [9] 0 0
Takapuna
Country [10] 0 0
United Kingdom
State/province [10] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01574339