Robot-controlled capsule endoscopy for examining the upper gastrointestinal tract
Feasibility and Acceptability of Robot-controlled Magnet-Assisted Capsule Endoscopy Compared to Conventional Endoscopy of the Upper Gastrointestinal Tract in Children
This study tests a new way to use a magnet-controlled capsule that kids aged 11-16 can swallow to check their stomach and intestines for problems without needing sedation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 11 Years to 16 Years |
| Sex | All |
| Sponsor | Sheffield Children's NHS Foundation Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Trial ID | NCT06030518 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a magnet-assisted capsule endoscope to examine the upper gastrointestinal tract in children aged 11-16 years who experience abdominal pain. The capsule, which is swallowed, is steered through the stomach using an external magnet, allowing for a non-invasive examination without the need for sedation. This method aims to provide a comprehensive view of the stomach and duodenum while also enabling the examination of the small bowel. The study compares the diagnostic yield of this innovative approach to traditional endoscopy.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 11-16 years experiencing abdominal pain that requires investigation.
Not a fit: Patients with conditions such as dysphagia, small bowel strictures, or those who cannot swallow the capsule will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a safer and more comfortable alternative for children undergoing gastrointestinal examinations.
How similar studies have performed: Previous studies in adults have shown promising results with similar magnet-assisted capsule endoscopy approaches, suggesting potential for success in this pediatric population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Sheffield, South Yorkshire
- Sheffield Childrens NHS FT — Sheffield, South Yorkshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Shishu Sharma
- Email: shishusharma@nhs.net
- Phone: 01143053827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.