Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis (TempGES)

Indiana University

Status: Terminated

Conditions: Gastroparesis

Study type: Observational

Funder types: Other

Identifiers

NCT02164591

Temp GES

Details and patient eligibility

About

The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.

Full description

This study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of GES, and the feasibility and patient tolerability of endoscopic placement of temporary Gastric Electrical Stimulator (t-GES),

Enrollment: 19 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching

• Solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment*

  • retention at 2 hr: >60% or
  • retention at 4 hr: >10% *Based on International consensus on gastric scintigraphy

Exclusion criteria

• Gastric outlet, small bowel, or colon obstruction.
• Small bowel malrotation
• Inflammatory bowel disease
• Contraindication for surgical implantation of GES
• Presence of illness that may require MRI during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc.
• Significant comorbidity due to sever cardiovascular, renal, pulmonary, or liver disease.
• Significant coagulopathy
• Non-ambulatory patients: bed-ridden, nursing home resident, etc.
• Pregnancy
• Unable to give own informed consent
• Prisoners