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Gastric Capsule Examination for Iron Deficiency Anaemia

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Magnetically steerable pill camera (Microcam Navi, Intromedic Ltd, Seoul, Korea)
Flexible endoscope
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Iron Deficiency Anemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetically steerable pill camera

Arm Description

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.

Outcomes

Primary Outcome Measures

Diagnostic yield (pathology reporting form)
As completed on pathology reporting form
Gastric mucosal visibility (Assessed on a 1-5 scale )
Assessed on a 1-5 scale at specific gastric locations
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

Secondary Outcome Measures

Full Information

First Posted
October 9, 2014
Last Updated
January 3, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02282553
Brief Title
Gastric Capsule Examination for Iron Deficiency Anaemia
Official Title
Diagnosis of Upper Gastrointestinal Pathology in Patients With Recurrent/Refractory Iron Deficiency Anaemia: Magnetically Steerable Gastric Capsule Endoscopy Versus Conventional Gastroscopy.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 25, 2014 (Actual)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
May 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetically steerable pill camera
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetically steerable pill camera (Microcam Navi, Intromedic Ltd, Seoul, Korea)
Intervention Description
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
Intervention Name(s)
Flexible endoscope
Other Intervention Name(s)
Oesophagogastroduodenoscope
Intervention Description
The current standard for investigation of upper gastrointestinal disorders is flexible endoscopy; oesophagogastroduodenoscopy (OGD), also known as gastroscopy.
Primary Outcome Measure Information:
Title
Diagnostic yield (pathology reporting form)
Description
As completed on pathology reporting form
Time Frame
Baseline
Title
Gastric mucosal visibility (Assessed on a 1-5 scale )
Description
Assessed on a 1-5 scale at specific gastric locations
Time Frame
Baseline
Title
Patient comfort score (visual analogue and numeric rating scales on Patient Comfort Questionnaire document)
Description
Assessed using visual analogue and numeric rating scales on Patient Comfort Questionnaire document
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark McAlindon, MD
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

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Gastric Capsule Examination for Iron Deficiency Anaemia

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