Gastric Capsule Examination for Iron Deficiency Anaemia

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282553
• Other study ID #: STH18317
• Status: Completed
• Phase: N/A
• Start date: September 25, 2014
• Est. completion date: May 23, 2018

Study information

• Verified date: January 2019
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 23, 2018
• Est. primary completion date: May 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Device:
• Magnetically steerable pill camera (Microcam Navi, Intromedic Ltd, Seoul, Korea)
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.
• Flexible endoscope
The current standard for investigation of upper gastrointestinal disorders is flexible endoscopy; oesophagogastroduodenoscopy (OGD), also known as gastroscopy.

Locations

Country	Name	City	State
United Kingdom	Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield (pathology reporting form)	As completed on pathology reporting form	Baseline
Primary	Gastric mucosal visibility (Assessed on a 1-5 scale )	Assessed on a 1-5 scale at specific gastric locations	Baseline
Primary	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	Baseline