Robot Assisted Magnetically Controlled Capsule Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Non-inferiority of robot assisted magnetically controlled capsule endoscopy compared to upper GI endoscopy (OGD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Robot assisted magnetically controlled capsule endoscopy
干预措施: Robot assisted magnetically controlled capsule endoscopy (Diagnostic Test)
结局指标
主要结局
Non-inferiority of robot assisted magnetically controlled capsule endoscopy compared to upper GI endoscopy (OGD)
时间窗: From individual patient enrolment to completion and reporting of capsule endoscopy examination
The principal research objective that this study seeks to address is if robot assisted magnetically controlled capsule endoscopy may be safely and effectively used as an alternative to upper GI endoscopy (OGD) (i.e. it is non-inferior when compared to OGD) in the investigation of patients with iron deficiency anaemia. This will be achieved through a review of OGD reports, the findings of which will be recorded. These will be directly compared to the findings at robot assisted magnetically controlled capsule endoscopy and any differences noted. Cohen's kappa coefficient will be used to assess the degree of diagnostic agreement between OGD and robot assisted magnetically controlled capsule endoscopy, with reference to the total number of lesions and specific pathology detected.
次要结局
未报告次要终点