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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-03-31

Brief Summary

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In this study the investigators will recruit patients who have already had an upper gastrointestinal (GI) tract endoscopy (OGD) and lower GI tract investigations which did not identify the source of iron deficiency anaemia, and who need the small bowel to be investigated. This will comprise both patients who would have proceeded directly to small bowel capsule endoscopy (SBCE) under standard care and also those from whom an initial 'watch and wait' approach may have been adopted before proceeding to SBCE. The investigators propose to investigate these patients during a single patient visit to Leith Community Treatment Centre, Edinburgh, Scotland, with a CE marked robotic capsule system which can examine both the upper GI tract (i.e. the oesophagus and the stomach) and the small bowel in one investigation using a magnetic guided capsule.

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.

Detailed Description

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Conditions

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Iron Deficiency Anaemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Robot assisted magnetically controlled capsule endoscopy

Group Type OTHER

Robot assisted magnetically controlled capsule endoscopy

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged 18 and above
* 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

* Known or suspected gastrointestinal obstruction, strictures or fistulae
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

Central Contacts

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John N Plevris, MD, DM, PhD(E), FRCPE, FEBGH

Role: CONTACT

0131 242 1631

Rebecca K Grant, MBChB BSc(Hons) MA(Hons) MSc

Role: CONTACT

Facility Contacts

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John Howson

Role: primary

0131 536 6442

Kay S Doherty

Role: backup

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.

Reference Type BACKGROUND
PMID: 34555347 (View on PubMed)

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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