Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis

Not Applicable

Completed

Conditions: Gastric Stasis

Interventions: Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)

Registration Number: NCT00595621

Lead Sponsor: University of Kansas Medical Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MGP-1 ON	Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on for 6 weeks
MGP-1 OFF	Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)	Experimental Pacemaker on or off for 4 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Slow Wave Entrainment	12 Weeks	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

Secondary Outcome Measures

Name	Time	Method
The Percent (Percentage) of Gastric Retention of a Solid Meal	12 Weeks	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.
Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M))	12 Weeks	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.
Severity of Gastroparetic Symptoms	12 weeks	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.
Changes in Hemoglobin A1c (HbA1c) Level	12 Weeks	HbA1c was evaluated at the baseline and after completion of all the phases of the study
Changes in Hospital Admissions	12 Weeks	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.