Trials / Completed
CompletedNCT00595621
Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- University of Kansas Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) | Multi-Channel Phased Gastric Pacemaker (MGP-1) |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2009-06-01
- Completion
- 2009-06-01
- First posted
- 2008-01-16
- Last updated
- 2019-05-31
- Results posted
- 2019-05-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00595621. Inclusion in this directory is not an endorsement.