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MAGNETIC: MAGNET Ingestion in Children

Sponsor
University Hospital Southampton NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05375981
Collaborator
(none)
300
Enrollment
1
Location
15
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study aims to understand the incidence, management and outcomes of children who ingest a magnetic foreign body.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Magnet Ingestion in Children: a Prospective Surveillance Study
    Actual Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Apr 30, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of MAGNETIC Foreign Body Ingestion [Over 1 year from May 1st 2022]

    Secondary Outcome Measures

    1. Investigations and management of magnetic foreign body ingestion [Up to 28 days following ingestion]

      What investigations and treatments these children had

    2. Outcomes of magnetic foreign body ingestion [Up to 28 days following ingestion]

      What the outcomes were

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Magnetic foreign body ingestion 16 years of age or less

    Exclusion Criteria:

    Non ingested foreign body

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southampton Children's Hospital Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • University Hospital Southampton NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Southampton NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05375981
    Other Study ID Numbers:
    • CHI1116
    First Posted:
    May 17, 2022
    Last Update Posted:
    May 17, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Foreign Bodies

    Study Results

    No Results Posted as of May 17, 2022