Robot-controlled Magnet-Assisted Capsule Endoscopy

NCT06030518 | Completed

• 1 other identifier: SCH-2497
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Abdominal Pain; Upper Gastrointestinal Symptoms

Keywords

Upper GI endoscopy

Outcome Measures

Primary Outcomes (1)

• Acceptability of upper GI capsule endoscopy

  Compare acceptability of upper GI capsule endoscopy and OGD in children using UPC questionnaire.

  One year

Secondary Outcomes (2)

• Diagnostic Yield

  One year

• Prevalence of small bowel pathology

  One year

Study Arms (1)

Patient undergoing upper Gi endoscopy

EXPERIMENTAL

Children attending Sheffield Childrens' Hospital Gastroenterology out-patients departments between the ages of 11-16 years of age who require OGD to investigate abdominal pain or discomfort will be invited to take part in the study. Interventions The study will begin when capsule endoscopy is performed by a Clinical Research Fellow at the Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Trust.

Diagnostic Test: Magnet Assisted Capsule Endoscopy

Interventions

Magnet Assisted Capsule Endoscopy DIAGNOSTIC_TEST

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.

Patient undergoing upper Gi endoscopy

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Abdominal pain requiring investigation by OGD
• Participant must be willing to undergo both procedures (i.e. ingestion of the capsule and standard of care Oesophago-gastro duodenoscopy (OGD)
• Age 11-16 years inclusive

You may not qualify if:

• Dysphagia
• Inability to swallow capsule
• Small bowel stricture
• Disease associated with small bowel stricturing (Crohn's disease, previous small bowel surgery, previous abdominal or pelvic radiation therapy, long term daily (\>6 months) non-steroidal anti-inflammatory drug consumption)
• Pacemaker or other implantable electrical cardiac or neurological device
• Unable to speak English
• Participants who are pregnant or who have implantable electronic devices cannot take part in the study. Depending on their age and pubertal status the female patients will be offered a pregnancy test prior to any examinations. Capsule endoscopy is not advised during pregnancy.

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Sheffield Childrens NHS FT

Sheffield, South Yorkshire, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Abdominal Pain

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

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

Study Officials

• Shishu Sharma

  Sheffield Childrens NHS FT

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 11, 2023
• Study Start: March 9, 2022
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)