The Use of Robot Assisted Magnetically Controlled Capsule Endoscopy in Patients With Iron Deficiency Anaemia

NCT07197424 | Not Yet Recruiting DMC

• 4 other identifiers: REC Number: 25/YH/0132Sponsor number: AC25074IRAS Study ID: 349888R&D Number: 2025/0152
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency Anaemia

Keywords

capsule endoscopy; robot assisted magnetically controlled capsule endoscopy; iron deficiency anaemia

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of robot assisted magnetically controlled capsule endoscopy compared to upper GI endoscopy (OGD)

  The principal research objective that this study seeks to address is if robot assisted magnetically controlled capsule endoscopy may be safely and effectively used as an alternative to upper GI endoscopy (OGD) (i.e. it is non-inferior when compared to OGD) in the investigation of patients with iron deficiency anaemia. This will be achieved through a review of OGD reports, the findings of which will be recorded. These will be directly compared to the findings at robot assisted magnetically controlled capsule endoscopy and any differences noted. Cohen's kappa coefficient will be used to assess the degree of diagnostic agreement between OGD and robot assisted magnetically controlled capsule endoscopy, with reference to the total number of lesions and specific pathology detected.

  From individual patient enrolment to completion and reporting of capsule endoscopy examination

Study Arms (1)

Robot assisted magnetically controlled capsule endoscopy

OTHER

Diagnostic Test: Robot assisted magnetically controlled capsule endoscopy

Interventions

Robot assisted magnetically controlled capsule endoscopy 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.

Robot assisted magnetically controlled capsule endoscopy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Leith Community Treatment Centre

Edinburgh, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34555347 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

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

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

0131 242 1631; j.plevris@ed.ac.uk

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

CONTACT

rebecca.grant9@nhs.scot

Study Design

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

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 29, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)