Status:
UNKNOWN
Robot-controlled Magnet-Assisted Capsule Endoscopy
Lead Sponsor:
Sheffield Children's NHS Foundation Trust
Conditions:
Abdominal Pain
Upper Gastrointestinal Symptoms
Eligibility:
All Genders
11-16 years
Phase:
NA
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 identif...
Detailed Description
A capsule endoscope is a swallowable pill camera (26x11mm) which images the GI tract as it passes through under the action of peristalsis. It is a non-invasive test which does not require sedation or ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06030518
Start Date
March 9 2022
End Date
September 30 2023
Last Update
September 11 2023
Active Locations (1)
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1
Sheffield Childrens NHS FT
Sheffield, South Yorkshire, United Kingdom, S10 2TH