Gastric Capsule Examination for Iron Deficiency Anaemia

NCT ID: NCT02282553

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-25
• Study Completion Date: 2018-05-23

Brief 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.

Detailed 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.

Conditions

Iron Deficiency Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Magnetically steerable pill camera

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.

Group Type: EXPERIMENTAL

Magnetically steerable pill camera (Microcam Navi, Intromedic Ltd, Seoul, Korea)

Intervention Type: DEVICE

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

Intervention Type: DEVICE

The current standard for investigation of upper gastrointestinal disorders is flexible endoscopy; oesophagogastroduodenoscopy (OGD), also known as gastroscopy.

Interventions

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.

Intervention Type: DEVICE

Flexible endoscope

The current standard for investigation of upper gastrointestinal disorders is flexible endoscopy; oesophagogastroduodenoscopy (OGD), also known as gastroscopy.

Intervention Type: DEVICE

Other Intervention Names

Oesophagogastroduodenoscope

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark McAlindon, MD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH18317

Identifier Type: -

Identifier Source: org_study_id