Gastric Capsule Examination for Iron Deficiency Anaemia

NCT02282553 | Completed

• 1 other identifier: STH18317
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (3)

• Diagnostic yield (pathology reporting form)

  As completed on pathology reporting form

  Baseline

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

  Assessed on a 1-5 scale at specific gastric locations

  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

  Baseline

Study Arms (1)

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.

Device: Magnetically steerable pill camera (Microcam Navi, Intromedic Ltd, Seoul, Korea); Device: Flexible endoscope

Interventions

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

Magnetically steerable pill camera

Flexible endoscope DEVICE

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

Also known as: Oesophagogastroduodenoscope

Magnetically steerable pill camera

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mark McAlindon, MD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: November 4, 2014
• Study Start: September 25, 2014
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

GB (1)