N/A
Completed N=22
Multi-Channel Gastric Electrical Stimulation for the Treatment of Gastroparesis
Gastric Stasis
Source: ClinicalTrials.gov NCT00595621 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Percentage of Slow Wave Entrainment — 72; 70; 84; 78 percentage of slow waves entrainment
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.
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 | — |
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. Informational only — not medical advice.