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Sponsors and Collaborators: |
University of Kansas GI Stimulation, Inc. National Institutes of Health (NIH) American Diabetes Association |
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Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00595621 |
Investigate the safety and efficacy of multi-channel gastric electrical stimulation in the treatment of patients with severe diabetic gastroparesis refractory to standard therapy.
Condition | Intervention |
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Gastric Stasis |
Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis |
Estimated Enrollment: | 20 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Experimental Pacemaker on for 6 weeks
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Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
Multi-Channel Phased Gastric Pacemaker (MGP-1)
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2: Active Comparator
Experimental Pacemaker on or off for 4 weeks
|
Device: Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1)
Multi-Channel Phased Gastric Pacemaker (MGP-1)
|
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: | Richard W. McCallum, MD | University of Kansas |
Responsible Party: | University of Kansas Medical Center ( Richard W. McCallum, MD ) |
Study ID Numbers: | 9459 |
Study First Received: | January 7, 2008 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00595621 |
Health Authority: | United States: Institutional Review Board |
Paralysis Signs and Symptoms Digestive System Diseases Stomach Diseases |
Gastrointestinal Diseases Neurologic Manifestations Gastroparesis |