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临床试验/NCT02282553
NCT02282553已完成不适用

Diagnosis of Upper Gastrointestinal Pathology in Patients With Recurrent/Refractory Iron Deficiency Anaemia: Magnetically Steerable Gastric Capsule Endoscopy Versus Conventional Gastroscopy.

Sheffield Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Diagnostic yield (pathology reporting form)

研究概览

简要总结

This is a pilot prospective single blind controlled trial comparing magnetically steerable gastric capsule endoscopy to conventional oesophagogastroduodenoscopy in diagnosing upper gastrointestinal pathology in patients with recurrent/refractory iron-deficient anaemia.

详细描述

Gastroscopy (OGD) is a useful test for investigating a variety of suspected upper GI disorders. But it is uncomfortable for patients and incurs the risk of intubation and sedation, plus a large proportion of procedures reveal insignificant or no pathology. Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, noninvasive and well tolerated.

The use of CE is traditionally restricted to the small bowel, although newer capsules to image the oesophagus and colon are currently in use. Previous capsules have failed to adequately image the stomach due to its large volume and rugal folds. Recently a magnetic capsule and handheld magnet has been developed (Microcam Navi, Intromedic Ltd, Seoul, Korea) to enable an element of manoeuvrability of the capsule. This is unnecessary in the small bowel where the capsule is propelled along its' tubular structure by peristalsis, but in the capacious stomach this may allow the capsule to be steered to examine all areas of the stomach.

The investigators have already conducted two feasibility studies in porcine models with promising results and a trial is currently underway using this equipment to steer the small bowel capsule through the stomach into the duodenum. The next logical step is to compare this technique to the conventional standard of upper GI investigation; OGD. Patients with recurrent or refractory iron deficiency anaemia require a combination of gastroscopy and small bowel capsule endoscopy as part of their diagnostic investigations. The investigators wish to undertake a pilot prospective single blind controlled trial comparing magnetically steerable gastric capsule examination to conventional OGD in diagnosing upper gastrointestinal pathology in patients with recurrent/refractory iron deficiency anaemia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 20 years and over.
  • Patients with recurrent/refractory iron deficiency anaemia who require a gastroscopy and small bowel capsule endoscopy as part of their diagnostic investigations.

排除标准

  • Patients under the age of 20 years.
  • Patients with a permanent pacemaker, implantable cardioverter defibrillator or REVEAL device.
  • Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators.
  • Patients that are pregnant.
  • Patients who are unable to understand or speak English.

研究组 & 干预措施

Magnetically steerable pill camera

Experimental

Capsule endoscopy uses a swallowable pill camera which passes through the GI tract by the action of peristalsis. The procedure utilizes a battery powered wireless capsule to transmit images of the gastrointestinal tract as it passes through the small intestine. The images are later downloaded to a computer and reviewed by a trained physician. Magnetically steerable gastric capsule endoscopy uses a pill camera containing a small amount of magnetic material, that can be manoeuvred in the gut and intestine by the physician using a handheld magnet. This technique will be compared to conventional gastroscopy which uses a flexible endoscope. Both techniques will be used to diagnose upper gastrointestinal pathology in patients with recurrent/refractory iron deficient anemia.

干预措施: Magnetically steerable pill camera (Microcam Navi, Intromedic Ltd, Seoul, Korea) (Device)

Magnetically steerable pill camera

Experimental

Capsule endoscopy uses a swallowable pill camera which passes through the GI tract by the action of peristalsis. The procedure utilizes a battery powered wireless capsule to transmit images of the gastrointestinal tract as it passes through the small intestine. The images are later downloaded to a computer and reviewed by a trained physician. Magnetically steerable gastric capsule endoscopy uses a pill camera containing a small amount of magnetic material, that can be manoeuvred in the gut and intestine by the physician using a handheld magnet. This technique will be compared to conventional gastroscopy which uses a flexible endoscope. Both techniques will be used to diagnose upper gastrointestinal pathology in patients with recurrent/refractory iron deficient anemia.

干预措施: Flexible endoscope (Device)

结局指标

主要结局

Diagnostic yield (pathology reporting form)

时间窗: Baseline

As completed on pathology reporting form

Gastric mucosal visibility (Assessed on a 1-5 scale )

时间窗: Baseline

Assessed on a 1-5 scale at specific gastric locations

Patient comfort score (visual analogue and numeric rating scales on Patient Comfort Questionnaire document)

时间窗: Baseline

Assessed using visual analogue and numeric rating scales on Patient Comfort Questionnaire document

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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