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Идёт набор NCT07197424

The Use of Robot Assisted Magnetically Controlled Capsule Endoscopy in Patients With Iron Deficiency Anaemia

Без фазы С лечением Iron Deficiency Anaemia

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: Robot assisted magnetically controlled capsule endoscopy.
Кому может быть актуально
Состояния в реестре: Iron Deficiency Anaemia. 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
Великобритания
Следующий шаг
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Официальное название

Robot Assisted Magnetically Controlled Capsule Endoscopy

Обзор

In this study the investigators will recruit patients who have already had an upper gastrointestinal (GI) tract endoscopy (OGD) and lower GI tract investigations which did not identify the source of iron deficiency anaemia, and who need the small bowel to be investigated. This will comprise both patients who would have proceeded directly to small bowel capsule endoscopy (SBCE) under standard care and also those from whom an initial 'watch and wait' approach may have been adopted before proceeding to SBCE. The investigators propose to investigate these patients during a single patient visit to Leith Community Treatment Centre, Edinburgh, Scotland, with a CE marked robotic capsule system which can examine both the upper GI tract (i.e. the oesophagus and the stomach) and the small bowel in one investigation using a magnetic guided capsule. The aim of the study is to compare the findings from OGD with the robotic capsule system and to determine if such a system may safely replace OGD - thus examining the upper GI tract and small bowel for IDA in one less invasive investigation. This has the potential to decrease patient discomfort, stress and anxiety, while also reducing pressure on busy endoscopy departments, helping to ensure that the right patients receive the right investigations in a timely manner.

Вмешательства

  • Диагностический тест Robot assisted magnetically controlled capsule endoscopy
    Examination of the upper GI tract (oesophagus and stomach) with robot assisted magnetically controlled capsule endoscopy. Examination of the small bowel will be completed using the same capsule, however it will not be robot assisted.

Первичные конечные точки

  • Non-inferiority of robot assisted magnetically controlled capsule endoscopy compared to upper GI endoscopy (OGD) [Срок оценки: From individual patient enrolment to completion and reporting of capsule endoscopy examination]

Критерии участия

Критерии включения

  • Adult patients aged 18 and above
  • Confirmed diagnosis of iron deficiency anaemia (either recent onset or recurrent)
  • No significant cause for iron deficiency anaemia previously identified on upper GI endoscopy, colonoscopy or CT colonography
  • Patients who would either have proceeded directly to small bowel capsule endoscopy (SBCE) or who would have had an initial 'watch and wait' period prior to undergoing SBCE

Критерии исключения

  • Known or suspected gastrointestinal obstruction, strictures or fistulae
  • Previous abdominal surgery
  • Dysphagia
  • Patients with a pacemaker, defibrillator or other implanted electronic device
  • In vivo retention with medical metal fittings - shunts, plates, stents or clips
  • A history of metal fragments in the eyes or elsewhere in the body
  • Confirmed or possible pregnancy
  • Patients who are not deemed to have capacity according to the Adults with Incapacity Act
  • Patients who are currently part of another research study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Великобритания · 1 центр
  • Leith Community Treatment Centre — Edinburgh

Публикации

  • Xiao YF, Wu ZX, He S, Zhou YY, Zhao YB, He JL, Peng X, Yang ZX, Lv QJ, Yang H, Bai JY, Fan CQ, Tang B, Hu CJ, Jie MM, Liu E, Lin H, Koulaouzidis A, Zhao XY, Yang SM, Xie X. Fully automated magnetically controlled capsule endoscopy for examination of the stomach and small bowel: a prospective, feasibility, two-centre study. Lancet Gastroenterol Hepatol. 2021 Nov;6(11):914-921. doi: 10.1016/S2468-12 PMID 34555347

Идентификаторы

NCT: NCT07197424 · REC Number: 25/YH/0132 · Sponsor number: AC25074 · IRAS Study ID: 349888 · R&D Number: 2025/0152

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗