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Набор по приглашению NCT04074356

Non-invasive Markers of Esophageal Function in Adults

Без фазы С лечением Dysphagia

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: Clinical measure questionnaires, EESG, MESG, High resolution manometry (HRM).
Кому может быть актуально
Состояния в реестре: Dysphagia. Базовые параметры: от 18 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
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Обзор

The investigator proposes to study electrical activity reflective of esophageal motility in adults noninvasively by the use of multichannel electroesophagogram (EESG) and magnetoesophagogram (MESG) recordings.

Подробное описание

Dysphagia, or difficulty with swallowing, is a common symptom affecting nearly 9.4 million individuals or 4% of the US population. High resolution esophageal manometry is currently considered the gold standard test for evaluation and diagnosis of esophageal motility disorders, but given that it requires trans-nasal placement in a conscious patient, this test is highly uncomfortable and associated with significant patient dissatisfaction. There are currently no noninvasive tests or markers available to test esophageal function and motility.

In the upper gastrointestinal system, as in the heart, disruption of the electrical syncytium in disease produces measurable dysrhythmia. Recent modifications of the standard electrogastrogram (EGG) that have increased the number of leads to 25 (termed high-resolution EGG) have allowed enhanced spatio-temporal resolution of electric slow wave activity, and newer analytic techniques. Additionally, the magnetogastrogram (MGG) overcomes many of the inherent limitations of the standard EGG. The goal of this proposal is to harness similar technologies applied to the esophagus to develop high-resolution electroesophagogram (EESG) and magnetoesophagogram (MESG) as noninvasive clinical methods to quantify esophageal function and motility disorders, which could guide intervention for a large number of adult patients.

The main aims in this proposal are to develop a mathematical model of esophageal function and characterize phenotypes of esophageal motility disorders using EESG/MESG in healthy controls and esophageal dysmotility patients and determine how EESG/MESG rhythm and pattern abnormalities relate to physiologic function.

Вмешательства

  • Другое Clinical measure questionnaires
    Collection of patient reported symptoms and perception of health
  • Диагностический тест EESG
    Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
  • Диагностический тест MESG
    MESG measures spatiotemporal properties of magnetic fields from the esophageal slow wave and allows characterization of the propagation of the slow wave in addition to evaluation of its frequency and power distribution
  • Диагностический тест High resolution manometry (HRM)
    Dysphagia subjects will have undergone standard of care HRM to determine placement in the achalasia or hypercontractile/spastic disorder arms

Первичные конечные точки

  • Presence of diagnostic pattern [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • Adults ≥ 18 years of age who are undergoing HRM for routine standard of care evaluation for esophageal motility.
  • Normal control participants (ages ≥ 18 years) who have no known gastrointestinal complications.

Критерии исключения

  • Those with claustrophobia who cannot lie still under the SQUID for the length of time required
  • Due to interference with signal acquisition, subjects with contraindication to undergoing an MRI scan as noted in the MRI Safety checklist by Vanderbilt University Medical Center (such as with heart pacemakers, metal implants, or metal chips or clips) will not undergo SQUID, but can still be eligible to do cutaneous EESG.
  • Morbid obesity (these patients are potentially unable to lie under the current generation of SQUID devices)
  • Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT04074356 · 191280

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗