Study of Enhanced Programming Stimulation with the Enterra® Therapy System

Inclusion criteria

• Completed informed consent process with signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged ≥18 or ≤70 years at time of Enterra® therapy implantation
• Diagnosed with idiopathic or diabetic gastroparesis
• Delayed solid-phase gastric emptying study (Eggbeaters™ test meal), completed within one year of patient enrollment in the study. Gastroparesis defined as > 60% retained at 2 hours and/or >10% retained at 4 hours
• Investigator confirms normal endoscopy within one year of enrollment in the study
• GCSI-DD score for nausea severity during the qualifying Baseline Period averaging 2.5 or more per week and vomiting averaging 5 or more episodes per week

Exclusion criteria

• Post-surgical gastroparesis (e.g., fundoplication, Billroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator
• History of pyloroplasty or pyloromyotomy or G-POEM
• Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study
• Active H. pylori infection
• Significant hepatic injury (elevated ALT, AST, bilirubin)
• Metabolic, mechanical, or mucosal inflammatory causes that may explain GI symptoms such as gallbladder disease, small bowel bacterial overgrowth, IBS, inflammatory bowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction
• Patients with significant cardiac or cardiovascular disease, malignancy, or other conditions
• Participation in other clinical studies
• Use of narcotics more than three days per week or other drugs that may affect motility (e.g., Glucagon-like peptide 1 (GLP-1) agonist drug)
• Cannabis and/or cannabinoid use that exceeds either:

• Greater than 3 days of usage per week with 2 or less occurrences each day of use, or
• Greater than 3 grams of total usage per week
• Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension
• Subject experiences discomfort during stimulation assessment that cannot be tolerated
• Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications
• Evidence of a failed response to temporary gastric electrical stimulation