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Идёт набор NCT03669874

Endoscopic Fundoplication With MUSE System

— Наблюдательное Gastro-esophageal Reflux Endoscopic Fundoplication

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: Endoscopic fundoplication.
Кому может быть актуально
Состояния в реестре: Gastro-esophageal Reflux, Endoscopic Fundoplication. 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
Италия
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

Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients

Обзор

This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives: * Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of: * effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores * effect on the use and dosage of proton pump inhibitors (PPI) * feasibility and safety of the endoluminal fundoplication procedure * Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure. The study design includes the following phases: \*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI * 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI * 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI * Yearly clinical follow-up (up to 6 years): PPI use GERD-HRQL and RSI questionnaires scores OFF PPI

Вмешательства

  • Устройство Endoscopic fundoplication
    Endoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication. The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the

Первичные конечные точки

  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Срок оценки: change from baseline GERD-HRQL at 6 months]
  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Срок оценки: change from baseline GERD-HRQL at 12 months]
  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Срок оценки: change from baseline GERD-HRQL at 24 months]
  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Срок оценки: change from baseline GERD-HRQL at 3 years]
  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Срок оценки: change from baseline GERD-HRQL at 4 years]
  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Срок оценки: change from baseline GERD-HRQL at 5 years]
  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score [Срок оценки: change from baseline GERD-HRQL at 6 years]
  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [Срок оценки: change from baseline RSI at 6 months]
  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [Срок оценки: change from baseline RSI at 12 months]
  • To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [Срок оценки: change from baseline RSI at 24 months]
Вторичные конечные точки (12)
  • To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [Срок оценки: change from baseline hiatal hernia size at 6 months]
  • To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [Срок оценки: change from baseline hiatal hernia size at 12 months]
  • To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [Срок оценки: change from baseline Hill's grade at 6 months]
  • To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [Срок оценки: change from baseline Hill's grade at 12 months]
  • To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [Срок оценки: change from baseline Jobe's lenght at 6 months]
  • To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [Срок оценки: change from baseline Jobe's lenght at 12 months]
  • To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [Срок оценки: change from baseline esophagitis' grade at 6 months]
  • To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [Срок оценки: change from baseline esophagitis' grade at 12 months]
  • To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [Срок оценки: change from baseline DeMeester score at 6 months]
  • To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [Срок оценки: change from baseline DeMeester score at 12 months]
  • To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [Срок оценки: change from baseline AET at 6 months]
  • To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [Срок оценки: change from baseline AET at 12 months]

Критерии участия

Критерии включения

  • Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
  • Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
  • Indication to surgical fundoplication
  • Patients available for a long-term follow-up

Критерии исключения

  • Hiatal hernia ≥ 3 cm
  • Major esophageal motility disorder
  • Esophageal stenosis
  • Malignant neoplasia (except minor superficial skin neoplasm)
  • Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
  • Previous cardiac, thoracic or upper GI surgery
  • BMI >40
  • Pregnancy or breast feeding

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Pier Alberto Testoni — Milan

Публикации

  • Testoni SGG, Cilona MB, Mazzoleni G, Fanti L, Ribichini E, Cavestro GM, Esposito D, Viale E, Notaristefano C, Zuppardo RA, Azzolini F, Passaretti S, Testoni PA. Transoral incisionless fundoplication with Medigus ultrasonic surgical endostapler (MUSE) for the treatment of gastro-esophageal reflux disease: outcomes up to 3 years. Surg Endosc. 2022 Jul;36(7):5023-5031. doi: 10.1007/s00464-021-08860-w PMID 34799745
  • Testoni PA, Testoni S, Mazzoleni G, Pantaleo G, Cilona MB, Distefano G, Fanti L, Antonelli M, Passaretti S. Transoral incisionless fundoplication with an ultrasonic surgical endostapler for the treatment of gastroesophageal reflux disease: 12-month outcomes. Endoscopy. 2020 Jun;52(6):469-473. doi: 10.1055/a-1124-3187. Epub 2020 Mar 18. PMID 32187630

Идентификаторы

NCT: NCT03669874 · MUSE/2015

Первоисточники (государственные реестры)

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