A multicentre pragmatic clinical investigation to assess the efficacy of TransiCap MRI marker device in magnetic resonance imaging in paediatric constipation (MAGIC2)

ottingham University Hospitals NHS Trust0 sites436 target enrollmentApril 2, 2020

Overview

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33093366/ (added 08/07/2024)

Registry

who.int

Start Date

April 2, 2020

End Date

October 2, 2022

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

ottingham University Hospitals NHS Trust

•1\. Children aged 7 – 18 years old
•2\. Able to give assent/consent or have a parent/carer able to give informed consent
•3\. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the clinical investigation
•4\. Children diagnosed with clinical diagnosis of constipation

•1\. Female participants who are pregnant, lactating or planning pregnancy during the course of the clinical investigation. This will be self\-reported
•2\. Any history of gastrointestinal surgery that could affect gastrointestinal function, such as colectomy or small bowel resection
•3\. Existing ACE procedure before the first MRI scan
•4\. Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
•5\. Inability to lie flat and relatively still for less than 5 minutes
•6\. Poor understanding of English language
•7\. The following disease or disorder: bowel stricture disease, Crohn’s or any difficulty in swallowing (dysphagia), Hirschsprung disease, congenital anorectal malformations, paediatric pseudo\-obstruction syndrome
•8\. Currently using the following drugs influencing drug motility:
•8\.1\. Opioid analgesics (tramadol, morphine, fentanyl, oxycodone, co\-codamol and codydramoland)
•8\.2\. Antispasmodic Buscopan (hyoscine butylbromide, also known as scopolamine butylbromide)