NCT05375981

Brief Summary

One year national observational surveillance study of children who ingest a magnetic foreign body

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

May 4, 2022

Last Update Submit

April 16, 2024

Conditions

Foreign Bodies

Outcome Measures

Primary Outcomes (1)

  • Incidence of MAGNETIC Foreign Body Ingestion

    Over 1 year from May 1st 2022

Secondary Outcomes (2)

  • Investigations and management of magnetic foreign body ingestion

    Up to 28 days following ingestion

  • Outcomes of magnetic foreign body ingestion

    Up to 28 days following ingestion

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Definite magnetic foreign body ingestion in children \<16yrs

You may qualify if:

  • Magnetic foreign body ingestion
  • years of age or less

You may not qualify if:

  • Non ingested foreign body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southampton Children's Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Foreign Bodies

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 17, 2022

Study Start

May 1, 2022

Primary Completion

April 30, 2023

Study Completion

December 31, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)