N/A
N=22
Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
Gastric Stasis
Bottom Line
View on ClinicalTrials.gov: NCT00595621 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Percentage of Slow Wave Entrainment — 72; 70; 84; 78 percentage of slow waves entrainment
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enterra Multi-Channel Phased Gastric Pacemaker (MGP-1) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Slow Wave Entrainment |
72; 70; 84; 78 | — |
| SECONDARY The Percent (Percentage) of Gastric Retention of a Solid Meal |
46; 36; 33; 42 | — |
| SECONDARY Severity of Gastroparetic Symptoms |
13; 14; 6; 16 | — |
| SECONDARY Changes in Quality of Life (QoL) Assessment (Physical (P) and Mental (M)) |
60; 30; 55; 40 | — |
| SECONDARY Changes in Hemoglobin A1c (HbA1c) Level |
8.1; 8.2 | — |
| SECONDARY Changes in Hospital Admissions |
1.5; 2.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00595621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.