Study of Enhanced Programming Stimulation with the Enterra® Therapy System

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Enterra Therapy System
  The Enterra® Therapy System for gastric electrical stimulation (GES) is indicated for the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.

Первичные конечные точки

• Change in Vomiting Absolute Frequency [Срок оценки: 3 Months]
• Change in Nausea Severity Score [Срок оценки: 3 Months]

Вторичные конечные точки (8)

• Change in Vomiting Absolute Frequency [Срок оценки: 6 Months]
• Change in Nausea Severity Score [Срок оценки: 6 Months]
• Change in Total Symptom Score [Срок оценки: 3 Months]
• Change in Total Symptom Score [Срок оценки: 6 Months]
• Change in Quality of Life Score [Срок оценки: 3 Months]
• Change in Quality of Life Score [Срок оценки: 6 Months]
• Change in Vomiting Absolute Frequency [Срок оценки: 1 Month]
• Change in Nausea Severity Score [Срок оценки: 1 Month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 6 центров

• University of South Florida — Tampa
• University of Louisville — Louisville
• Henry Ford Health System — Detroit
• Washington University — St Louis
• Foundation for Surgical Innovation — Portland
• Benaroya Research Institute at Virginia Mason — Seattle

Идентификаторы

NCT: NCT06560307 · CLN 001-PR-01218

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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