Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/14/2017 |
| Start Date: | February 2006 |
| End Date: | June 2009 |
Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the
treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
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
DM gastroparetics.
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
DM gastroparetics.
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
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