The Use of Robot Assisted Magnetically Controlled Capsule Endoscopy in Patients With Iron Deficiency Anaemia
NCT ID: NCT07197424
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-12-31
2027-03-31
Brief Summary
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The aim of the study is to compare the findings from OGD with the robotic capsule system and to determine if such a system may safely replace OGD - thus examining the upper GI tract and small bowel for IDA in one less invasive investigation. This has the potential to decrease patient discomfort, stress and anxiety, while also reducing pressure on busy endoscopy departments, helping to ensure that the right patients receive the right investigations in a timely manner.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Robot assisted magnetically controlled capsule endoscopy
Robot assisted magnetically controlled capsule endoscopy
Examination of the upper GI tract (oesophagus and stomach) with robot assisted magnetically controlled capsule endoscopy. Examination of the small bowel will be completed using the same capsule, however it will not be robot assisted.
Interventions
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Robot assisted magnetically controlled capsule endoscopy
Examination of the upper GI tract (oesophagus and stomach) with robot assisted magnetically controlled capsule endoscopy. Examination of the small bowel will be completed using the same capsule, however it will not be robot assisted.
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of iron deficiency anaemia (either recent onset or recurrent)
* No significant cause for iron deficiency anaemia previously identified on upper GI endoscopy, colonoscopy or CT colonography
* Patients who would either have proceeded directly to small bowel capsule endoscopy (SBCE) or who would have had an initial 'watch and wait' period prior to undergoing SBCE
Exclusion Criteria
* Previous abdominal surgery
* Dysphagia
* Patients with a pacemaker, defibrillator or other implanted electronic device
* In vivo retention with medical metal fittings - shunts, plates, stents or clips
* A history of metal fragments in the eyes or elsewhere in the body
* Confirmed or possible pregnancy
* Patients who are not deemed to have capacity according to the Adults with Incapacity Act
* Patients who are currently part of another research study
18 Years
ALL
No
Sponsors
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NHS Lothian
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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John N Plevris, MD, DM, PhD(E), FRCPE, FEBGH
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
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Leith Community Treatment Centre
Edinburgh, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Xiao YF, Wu ZX, He S, Zhou YY, Zhao YB, He JL, Peng X, Yang ZX, Lv QJ, Yang H, Bai JY, Fan CQ, Tang B, Hu CJ, Jie MM, Liu E, Lin H, Koulaouzidis A, Zhao XY, Yang SM, Xie X. Fully automated magnetically controlled capsule endoscopy for examination of the stomach and small bowel: a prospective, feasibility, two-centre study. Lancet Gastroenterol Hepatol. 2021 Nov;6(11):914-921. doi: 10.1016/S2468-1253(21)00274-0. Epub 2021 Sep 21.
Other Identifiers
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Sponsor number: AC25074
Identifier Type: OTHER
Identifier Source: secondary_id
IRAS Study ID: 349888
Identifier Type: OTHER
Identifier Source: secondary_id
R&D Number: 2025/0152
Identifier Type: OTHER
Identifier Source: secondary_id
REC Number: 25/YH/0132
Identifier Type: -
Identifier Source: org_study_id
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