GERDNCT02210975
An Investigation of Electrical Stimulation on Gastroesophageal Reflux Disease (GERD) in Patients After Sleeve Gastrectomy
A study testing LES-Stimulation Device in people with GERD and Sleeve Gastrectomy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GERD, Sleeve Gastrectomy
- What is being tested?
- LES-Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
- Weight change of +/- 10% of the EWL (Excess Weight Loss) in the 3 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, 6229 HX
Nicolaas F Rinsma, MD, +31433884190, n.rinsma@maastrichtuniversity.nl
Nicole D. Bouvy, MD PhD
About this study
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.
- Conditions
- GERD, Sleeve Gastrectomy
- Being tested
- LES-Stimulation Device
- Keywords
- GERD, LES, Sleeve Gastrectomy, Electrical Stimulation Therapy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LES-Stimulation DeviceDevice
Also called EndoStim b.v.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation Therapy | Experimental | Not described Receives: Device: LES-Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period.
Measured: 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) .
Measured: Baseline, 6 and 12 month follow up
Secondary outcomes (4)
pH-monitoring
The change in 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 and at 12 months.
Measured: Baseline, 6 and 12 month FU
Questionnairres, symptom diary
Change in symptoms frequency and severity at 6 months vs. baseline and at 12 months vs. baseline as measured by patient symptom diary, structured GI questionnaire, and patients quality of life measured by SF-12.
Measured: baseline, 6 and 12 month FU
Anti-secretory medication use
Change in anti-secretory medication use as evaluated during the two weeks prior to the 6 mo and 12 mo follow up compared to baseline.
Measured: Baseline, 6 and 12 month FU
HR-manometry
Change in LES end expiratory pressure (LESPpre) and the on-stimulation LES end expiratory pressure (LESPpost) at 6 months and 12 months in mmHg.
Measured: Baseline, 6 and 12 month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- EndoStim Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210975
- Sponsor's protocol ID
- NL4834906814
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Electrical Stimulation on Gastroesophageal Reflux Disease (GERD) in Patients After Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02210975
- Acronym / sponsor ID
- NL4834906814
- Conditions
- GERD, Sleeve Gastrectomy
- Keywords
- GERD, LES, Sleeve Gastrectomy, Electrical Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- EndoStim Inc.
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation Therapy | Experimental | Device: LES-Stimulation Device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LES-Stimulation DeviceAlso: EndoStim b.v. | Device | Electrical Stimulation Therapy |
Primary outcome
The incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period.
Time frame: up to 12 month follow-up
Efficacy - Disease specific quality of life
Time frame: Baseline, 6 and 12 month follow up
The change in patient's GERD-HRQL, where applicable, from baseline (as measured while off PPI) .
4 secondary outcomes
pH-monitoring
Time frame: Baseline, 6 and 12 month FU
Questionnairres, symptom diary
Time frame: baseline, 6 and 12 month FU
Anti-secretory medication use
Time frame: Baseline, 6 and 12 month FU
HR-manometry
Time frame: Baseline, 6 and 12 month FU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LES-Stimulation Device in people with GERD and Sleeve Gastrectomy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolaas F Rinsma, MD (+31433884190, n.rinsma@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period. (time frame: up to 12 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.