NCT05082129

Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)

A Multicentre Pragmatic Clinical Investigation to Assess the Efficacy of TransiCap MRI Marker Device in Magnetic Resonance Imaging in Paediatric Constipation (MAGIC2)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Constipation in children is a common problem. Managing these children is difficult, partly because they do not respond to laxatives and partly because their bowel problem cannot be defined. A "gut transit time" test can add information to help choose the best therapy but this is often not carried out because of the unsuitable radiation dose involved in the current methods such as X-ray. A new Magnetic Resonance Imaging (MRI) method to measure gut transit time using inert mini-capsules, the size of small pine nuts, has recently been developed and successfully trialled during a feasibility study. This main multicentre study will trial the mini-capsules in 436 paediatric constipation patients.

Detailed description

A fully powered, multi-centre, open label, pragmatic Randomised Controlled Trial (RCT) to test the use of the TransiCap MRI visible capsules to inform treatment selection and whether this leads to a change in rate of "treatment success" at 12 months after diagnosis. Two study arms will include 436 young patients that present at secondary or tertiary care with constipation. All participants will receive the TransiCap MRI Visible Capsules and the MRI scans at presentation, but only the participants in the intervention arm will have the results of their scan shared with the standard care team immediately. The intervention arm will therefore receive treatment which is informed by the TransiCap MRI transit time test. The participants in the control arm will instead receive standard care not informed by theTransiCap MRI visible capsules. The results of the scans will be shared with the standard care team after the patient's follow up of 12 months is complete. All participants will receive the TransiCap MRI visible capsules and the MRI scans

Conditions

• Constipation

Interventions

Type	Name	Description
DEVICE	TransiCap	The TransiCap device consists of small, completely inert mini-capsules that, once ingested, can be imaged inside the gastrointestinal tract using MRI, thereby creating a new MRI alternative to the radiopaque marker X-ray test to measure gut transit. The MRI mini- capsules are visualised in the gut using a single fat, water, in-phase and out-of-phase scan.

Timeline

• Start date: 2021-07-12
• Primary completion: 2023-07-12
• Completion: 2023-07-12
• First posted: 2021-10-18
• Last updated: 2023-09-05

Locations

1 site across 1 country: United Kingdom