Study of Enhanced Programming Stimulation with the Enterra® Therapy System

A vizsgálat adatai

Ki végzi

Enterra Medical, Inc.

Azonosító

NCT06560307

A regiszteradat frissítve

2024. november 15.

Eredeti leírás

The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures.A teljes eredeti leírásKevesebb

Examination of Programming with the Enterra® Therapy System in a Double-Blinded, Randomized, Prospective Study in the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation

The purpose of this research study is to evaluate if an enhanced Enterra device programming strategy will improve symptoms associated with gastroparesis, improve symptoms in a faster amount of time, and improve quality of life measures.

Participants in this study will be evaluated for study entry criteria, have an Enterra Therapy System implanted, and be randomly assigned to one of two programming strategies. Participants will answer daily questions about their gastroparesis symptoms on an application with their phone/tablet. Participants will answer quality of life questionnaires about their gastroparesis symptoms at monthly study visits.

Participants will be involved in the study for up to six months after treatment assignment.

Programming parameters in the study are within currently approved labeling.

Bevonási feltételek: 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.

Kizáró feltételek: 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); Previous diagnosis or history of orthostatic intolerance, e.g., POTS, neurocardiogenic syncope, orthostatic hypotension; 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; Active H. pylori infection; 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; Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications; Significant hepatic injury (elevated ALT, AST, bilirubin); Pregnancy or breastfeeding at the time of consent, or intent to become pregnant during the study; Participation in other clinical studies; 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; Subject experiences discomfort during stimulation assessment that cannot be tolerated; Evidence of a failed response to temporary gastric electrical stimulation.

ClinicalTrials.gov NCT06560307