An interventional study of Magnetically steerable pill camera (Microcam Navi, Intromedic Ltd, Seoul, Korea) and Flexible endoscope in Iron Deficiency Anemia, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Not applicable, Interventional, and Diagnostic
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.
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 48 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 207 studies on the registry; 26 are open to participants now.
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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.
Device: Magnetically steerable pill camera (Microcam Navi, Intromedic Ltd, Seoul, Korea) · Device: Flexible endoscope
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.
The current standard for investigation of upper gastrointestinal disorders is flexible endoscopy; oesophagogastroduodenoscopy (OGD), also known as gastroscopy.
Also known as: Oesophagogastroduodenoscope
Diagnostic yield (pathology reporting form)
As completed on pathology reporting form
Time frame: Baseline
Gastric mucosal visibility (Assessed on a 1-5 scale )
Assessed on a 1-5 scale at specific gastric locations
Time frame: Baseline
Patient comfort score (visual analogue and numeric rating scales on Patient Comfort Questionnaire document)
Assessed using visual analogue and numeric rating scales on Patient Comfort Questionnaire document
Time frame: Baseline
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Sheffield Teaching Hospitals NHS Foundation Trust