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Набор скоро начнётся NCT06589882

French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers

Наблюдательное Endoscopy Innovative Procedures

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: Effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques.
Кому может быть актуально
Состояния в реестре: Endoscopy, Innovative Procedures. 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
Франция
Следующий шаг
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Обзор

The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practices.

Подробное описание

Diagnostic and therapeutic digestive endoscopy has been booming over the last 10 years. Many new techniques in digestive tract or hepato-bilio-pancreatic endoscopy are introduced every year. France is the Western country with the most technical skills in terms of the number of experts relative to the size of its territory, but is lagging far behind in terms of the promotion and reimbursement of these techniques by health insurance funds. France is also experiencing difficulties in centralizing health data from the thousands of endoscopies performed in the country every year. Pooling this data across the country, following the example of certain European and international partners (the Dutch, English and Australians), would make it easier to exploit data from innovative, sometimes rare or confidential digestive endoscopy procedures, and to justify their reimbursement once their usefulness has been confirmed through large-scale descriptive prospective studies associated with national multicenter publications.

The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practi

Вмешательства

  • Другое Effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques
    Evaluate the effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques practiced in French expert centers over the next 10 years with the rate of technical success (procedure completed) and clinical success (cure) of the digestive pathology presented by the patient who indicated endoscopy without recourse to a new intervention (endoscopic or surgical) within 30 days of the procedure.

Первичные конечные точки

  • Evaluate the effectiveness of diagnostic, therapeutic and/or innovative endoscopic practiced in French expert centers over the next 10 years. [Срок оценки: 10 years]
Вторичные конечные точки (5)
  • Evaluate the safety of diagnostic and therapeutic and/or innovative endoscopic techniques performed in French expert centers over the next 10 years. [Срок оценки: 10 years]
  • Evaluate the secondary failure rate [Срок оценки: 10 years]
  • Evaluate operating time [Срок оценки: 10 years]
  • Evaluate inter-operator variability in efficacy [Срок оценки: 10 years]
  • Evaluate long-term efficacy [Срок оценки: 10 years]

Критерии участия

Критерии включения

  • Patients \> 18 yo
  • Patient able to give consent
  • Patient with innovative endoscopy

Критерии исключения

  • Opposition to participation in the present project to be notified in the file
  • Patient under court protection

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 2 центра
  • Chu Nimes — Nîmes
  • Hôpital Européen Georges Pompidou AP-HP — Paris

Идентификаторы

NCT: NCT06589882 · LOCAL/2024/LC-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗