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| Name | Class |
|---|---|
| EndoStim Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical Stimulation Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LES-Stimulation Device | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of any complications that are associated with the investigational stimulation device throughout the follow-up period. | 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) . | Baseline, 6 and 12 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 and 12 month FU |
| Questionnairres, symptom diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolaas F Rinsma, MD | Contact | +31433884190 | n.rinsma@maastrichtuniversity.nl | |
| Selwyn van Rijn, MD | Contact | +3143375021 | selwyn.van.rijn@mumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Recruiting | Maastricht | 6229 HX | Netherlands |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 28, 2018 | |
| Reset | Mar 15, 2019 | |
| Release | Sep 2, 2020 | |
| Reset | Sep 23, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 28, 2018 | Mar 15, 2019 | |||
| Sep 2, 2020 |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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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. |
| 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. | 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. | Baseline, 6 and 12 month FU |
| Sep 23, 2020 |
| D004066 | Digestive System Diseases |