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Robot-controlled Magnet-Assisted Capsule Endoscopy

NCT06030518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-10

No results posted yet for this study

Summary

Examination of the upper gastrointestinal tract (oesophagus, stomach and duodenum) involves passing a flexible tubular endoscope through the mouth into the stomach. It is commonly performed to identify the cause of abdominal pain, indigestion, diarrhoea and anaemia. As it is an invasive and uncomfortable test, it is usually performed under general anaesthetic in children. However, children and their parents worry about the nature of the procedure which does incur a small risk of both the anaesthetic and the endoscopy.

A capsule endoscope is a large pill-sized device containing a battery powered camera which can be swallowed. It was first devised to examine the small bowel (which begins with the duodenum and ends in the colon or large bowel) which is difficult to reach with conventional endoscopes and has been used in children aged over eight years since at least 2005. It is extremely well tolerated. However, it does not provide a comprehensive view of the whole surface area of the stomach which has a convoluted shape, large volume and is collapsed in the fasted state.

Recent research in adults shows that a capsule can be steered around a water-filled stomach using two joysticks to control the polarity and distance of an external robot magnet from the patient. This is much better tolerated and appears to be almost as good a diagnostic tool as conventional endoscopy. It has yet to be studied in children. We intend to compare patient acceptability of capsule endoscopy and gastroscopy and see if it is cost effective.

Conditions

Interventions

DIAGNOSTIC_TEST

Magnet Assisted Capsule Endoscopy

Procedures will be performed in the morning after an overnight fast. Patients wear a belt containing sensors and a data recorder. The patient will be asked to drink 500-1000ml (containing 80mg simethicone; volume depending on tolerance) immediately before swallowing the capsule. Gastric examination will proceed as previously described for a robot-controlled magnetic assisted capsule endoscopy. The whole procedure is anticipated to take 30-60 minutes. The patient will be discharged from hospital on completion of gastric examination but if clinically indicated will wear the belt for small bowel capsule study for eight hours to allow small bowel examination before detaching the equipment and returning it the following day. On completion of examination, the patient will be asked to complete a questionnaire about their capsule endoscopy experience. The full study (upper GI tract and small bowel) will then be downloaded onto the computer for formal reading and reporting.

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Shishu Sharma · Sheffield Childrens NHS FT

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2025-02-14
Completion
2025-02-14

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06030518 on ClinicalTrials.gov