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Идёт набор NCT05980455

Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Без фазы С лечением Gastroparesis Gastroparesis Nondiabetic Gastroparesis Due to Diabetes Mellitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Enterra® Therapy System.
Кому может быть актуально
Состояния в реестре: Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Randomized Study of Enterra Programming with Nocturnal Cycling in Gastroparetics

Обзор

The purpose of this research study is to evaluate if different Enterra® device programming methods active during sleeping hours can maintain gastroparesis-related symptom relief and quality of life measures. Participants in this study with existing Enterra® devices will be randomly assigned to one of three programming methods that will be active during sleep. 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 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

  • Percent Change in Weekly Vomiting Frequency by GCSI-DD [Срок оценки: 3 Months, 6 Months]
  • Scoring Change in Nausea Severity by GCSI-DD [Срок оценки: 3 Months, 6 Months]
Вторичные конечные точки (5)
  • Mean Change from Baseline in GCSI-DD Total Symptom Score [Срок оценки: 3 Months, 6 Months]
  • Mean Change from Baseline in GCSI-DD Nausea Severity [Срок оценки: 3 Months, 6 Months]
  • Mean Change from Baseline in GCSI-DD Weekly Vomiting Frequency [Срок оценки: 3 Months, 6 Months]
  • Mean Change from Baseline in PAGI-QoL Scores [Срок оценки: 3 Months, 6 Months]
  • Mean Change from Baseline in Quality of Sleep Scores [Срок оценки: 3 Months, 6 Months]

Критерии участия

In order to be eligible to participate in this study, a participant must meet all of the following 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 at time of informed consent;
  • Currently implanted with the Enterra® Therapy System (Enterra® II 37800 neurostimulator);
  • High GES output defined as remaining pulse generator expected life of > 9 months from enrollment and less than 4 years from the time of implant;
  • Stable gastroparesis symptoms, in the opinion of the investigator;
  • On stable medical therapy for gastroparesis symptoms;
  • On stable supplemental nutritional support during the month prior to enrollment;
  • English language comprehension to complete study-required assessments;
  • Reliable access to internet-connected smart device(s) to complete study-required assessments.

A participant who meets any of the following criteria will be excluded from participation in this study:

  • Post-surgical gastroparesis (e.g., fundoplication, Bilroth I or II) or other active stomach or gastrointestinal diseases disorders which could explain symptoms in the opinion of the investigator;
  • Subjects, in the opinion of the investigator, with profound nausea and/or vomiting at night;
  • Subjects, in the opinion of the investigator, with profound gastroparesis symptoms upon waking in the morning;
  • Subjects without a regular and defined sleep schedule;
  • Pregnancy, or subject that intends to become pregnant during participation in the study;
  • Chemical dependency;
  • Enterra lead impedance measurements ≥ 700 Ohms at screening visit;
  • Life expectancy < 1 year from conditions other than GI diseases;
  • Subjects with an underlying disease leading to follow-up by MRI outside of current MR conditional indications;
  • Participation in other clinical studies;
  • Subjects involved in current or past medical-related litigation;
  • Subjects with cognitive impairment or other characteristic that would limit subject's ability to complete study requirements.

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 · 2 центра
  • University of Louisville — Louisville
  • MNGI Digestive Health, P.A. — Coon Rapids

Идентификаторы

NCT: NCT05980455 · CLN 001-PR-00755

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗