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An Observer Blinded Comparison of MACE and Conventional Upper Gastrointestinal Endoscopy in Upper GI Bleeding (MACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02690376
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : September 23, 2019
IntroMedic USA Inc.
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:

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, non-invasive 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 (Mirocam 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. We have already conducted two feasibility studies in porcine models with promising results and a trial has already evaluated the equipment to steer the small bowel capsule through the stomach into the duodenum. An ongoing study is comparing the ability of this technique to examine the stomach against conventional OGD, in patients with recurrent iron deficiency anaemia. The next stop would be to compare the two modalities under other different conditions.

We wish to undertake a prospective single blind controlled trial comparing magnetically assisted capsule examination to conventional OGD in diagnosing upper gastrointestinal pathology in patients with gastrointestinal bleeding.

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Device: Magnetic Assisted Capsule Endoscopy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Observer Blinded Comparison of Magnetically Assisted Capsule Endoscopy and Conventional Upper Gastrointestinal Endoscopy in Upper GI Bleeding
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Magnetic Assisted Capsule Endoscopy
There is only one arm and its does not reach criteria for other options
Device: Magnetic Assisted Capsule Endoscopy
Swallowed magnetic capsule for endoscopy purposes
Other Name: MACE

Primary Outcome Measures :
  1. Diagnostic yield of pathology of MACE compared to gastroscopy. [ Time Frame: Baseline - one visit only ]

Secondary Outcome Measures :
  1. Mucosal visualisation of the oesophagus and major areas of the stomach during MACE. [ Time Frame: Baseline - one visit only ]
  2. Determine the number of patients with small bowel bleeding [ Time Frame: Baseline - one visit only ]
  3. Tolerability of MACE compared to gastroscopy [ Time Frame: Baseline - one visit only ]
  4. Duration of MACE compared to gastroscopy [ Time Frame: Baseline - one visit only ]
  5. Determine if MACE can be used to avoid unnecessary OGD or hospital admission [ Time Frame: Baseline - one visit only ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 18 years and over
  • Patients presenting with haematemesis (fresh blood or coffee grounds) and/or malaena within the previous 48 hours, who require a gastroscopy as part of their diagnostic investigations

Exclusion Criteria:

  • Patients under the age of 18 years or over the age of 80 years.
  • Patients who have a suspected UGIB and haemodynamic instability, i.e. hypotension (systolic blood pressure <100mmHg) and tachycardia (>100 bpm), requiring urgent resuscitation
  • Pre-endoscopy Rockall score >4 (patients with a lower pre-endoscopy Rockall score but haemodynamically unstable will still be excluded)
  • Active vomiting or haematemesis
  • 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 with dysphagia, odynophagia or known swallowing disorder
  • Patients with known Zenker's diverticulum
  • Patients with suspected bowel obstruction or bowel perforation
  • Patients with prior bowel obstruction
  • Patients with gastroparesis or known gastric outlet obstruction
  • Patients with known Crohn's disease
  • Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure)
  • Patients that are pregnant or lactating
  • Patients with altered mental status that would limit their ability to swallow
  • Patients with allergy to conscious sedation or metoclopramide
  • Patients unwilling to swallow the capsule
  • Patients unwilling to undergo a possible abdominal XR if suspected capsule retention occurs
  • Patients with known dementia affecting ability to consent
  • Patients who are unable to understand or speak English
  • Patients unable to provide written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02690376

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United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sheffield Teaching Hospitals FT Trust
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
IntroMedic USA Inc.
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Principal Investigator: Mark McAlindon, Dr Sheffield Teaching Hospitals NHS Trust

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust Identifier: NCT02690376     History of Changes
Other Study ID Numbers: STH19107
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases