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

University of Edinburgh

Status: Not yet enrolling

Conditions: Iron Deficiency Anaemia

Treatments: Diagnostic Test: Robot assisted magnetically controlled capsule endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT07197424

Sponsor number: AC25074 (Other Identifier)

R&D Number: 2025/0152 (Other Identifier)

REC Number: 25/YH/0132

IRAS Study ID: 349888 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Robot assisted magnetically controlled capsule endoscopy

Other group

Treatment:

Diagnostic Test: Robot assisted magnetically controlled capsule endoscopy