Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

Study Overview
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Brief Summary
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Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.

Detailed Description
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Evaluation of severe symptom control of nausea, vomiting, postprandial fullness, early satiety, bloating and discomfort related to drug refractory gastroparesis present as a GI complication in diabetic patients. External gastric pacemaker system will be placed at the same time of implantation of Enterra (internal gastric stimulator-permanent device) to assess symptoms, quality of life improvement and investigate the changes in gastric emptying time in diabetic gastroparesis.

Official Title
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Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

Conditions
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Gastric Stasis

Intervention / Treatment
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* Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe nausea and vomiting for at least 6 months Documented delayed gastric emptying Failed extensive medical treatment Exclusion Criteria: Previous gastric surgery Pregnancy or planned pregnancy Primary eating or swallowing disorders Scheduled or planned MRI testing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MGP-1 ON<br>Experimental Pacemaker on for 6 weeks | Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)<br>* Multi-Channel Phased Gastric Pacemaker (MGP-1)<br>|
| Active Comparator: MGP-1 OFF<br>Experimental Pacemaker on or off for 4 weeks | Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)<br>* Multi-Channel Phased Gastric Pacemaker (MGP-1)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Slow Wave Entrainment | Participants were monitored for up to 3 months. Measure is the percent of normal slow waves (2-4 cpm) generated by MGP-1 device while it was ON or OFF | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percent (Percentage) of Gastric Retention of a Solid Meal | The retention of a study meal was measured at baseline, 1,2,3 and 4 hours of the test. The percent of food retained in a stomach at 4 hours was compared when MGP-1 was ON and OFF. | 12 Weeks | 
| Severity of Gastroparetic Symptoms | Measure represents change in symptom severity as measured by a self assessment Symptom Interview Form evaluating severity of vomiting, nausea, early satiety, bloating, postprandial fullness, epigastric pain, and epigastric burning. Symptoms were rated from 0 - absence of symptom to 4 - extremely severe. The overall score was calculated from the sum of seven symptom sub-scores with a total possible score range of 0 - absence of all symptoms to 28 - all symptoms extremely severe. | 12 weeks | 
| Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M)) | Measure represents percentage change from baseline to end of study. QoL measured using the Short Form Health Survey (SF-36) questionnaire. The SF-36 is a generic measure of QoL. Physical QoL (Physical Component Summary; PCS) and emotional QoL (Mental Component summary; MCS) scale components of the survey used for outcome. Scores range from 0 to 100 with lower scores indicating more disability and higher scores less disability. | 12 Weeks | 
| Changes in Hemoglobin A1c (HbA1c) Level | HbA1c was evaluated at the baseline and after completion of all the phases of the study | 12 Weeks | 
| Changes in Hospital Admissions | Measured by days of hospitalization per patient. Number of days of hospitalization was recorded at baseline and after completion of all phases of the study. | 12 Weeks |