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NCT Number: NCT07197424

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

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.

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Key information

Conditions

Iron Deficiency Anaemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leith Community Treatment Centre

Edinburgh, United Kingdom

Location status: Recruiting

Location contact

John Howson

CONTACT

[email protected]

0131 536 6442

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

PRINCIPAL_INVESTIGATOR

Kay S Doherty

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

0131 242 1631

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

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

Robot Assisted Magnetically Controlled Capsule Endoscopy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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