Foreign BodiesMAGNETICNCT05375981
MAGNET Ingestion in Children
An observational study of Foreign Bodies, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
One year national observational surveillance study of children who ingest a magnetic foreign body Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Foreign Bodies
- How many people
- 366 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Definite magnetic foreign body ingestion in children <16yrs
Who may be able to join
- Magnetic foreign body ingestion
- 16 years of age or less
Who cannot join
- Non ingested foreign body
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southampton Children's Hospital
Southampton, SO16 6YD
About this study
Official title: Magnet Ingestion in Children: a Prospective Surveillance Study
One year national observational surveillance study of children who ingest a magnetic foreign body
Read the detailed description
The study aims to understand the incidence, management and outcomes of children who ingest a magnetic foreign body.
- Conditions
- Foreign Bodies
- Medical subject headings
- Foreign Bodies
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MAGNETIC Foreign Body Ingestion
Measured: Over 1 year from May 1st 2022
Secondary outcomes (2)
Investigations and management of magnetic foreign body ingestion
What investigations and treatments these children had
Measured: Up to 28 days following ingestion
Outcomes of magnetic foreign body ingestion
What the outcomes were
Measured: Up to 28 days following ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 May 2022
- Primary completion30 Apr 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign BodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375981
- Sponsor's protocol ID
- CHI1116
- Acronym
- MAGNETIC
- Status last verified
- Apr 2024
- First submitted
- 4 May 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnet Ingestion in Children: a Prospective Surveillance Study
- ClinicalTrials.gov ID
- NCT05375981
- Acronym / sponsor ID
- MAGNETIC / CHI1116
- Conditions
- Foreign Bodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One year national observational surveillance study of children who ingest a magnetic foreign body
Detailed description
The study aims to understand the incidence, management and outcomes of children who ingest a magnetic foreign body.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Definite magnetic foreign body ingestion in children <16yrs
Key inclusion criteria (2 listed)
- Magnetic foreign body ingestion
- 16 years of age or less
Key exclusion criteria (1 listed)
- Non ingested foreign body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of MAGNETIC Foreign Body Ingestion
Time frame: Over 1 year from May 1st 2022
2 secondary outcomes
Investigations and management of magnetic foreign body ingestion
Time frame: Up to 28 days following ingestion
Outcomes of magnetic foreign body ingestion
Time frame: Up to 28 days following ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foreign Bodies, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MAGNETIC Foreign Body Ingestion (time frame: Over 1 year from May 1st 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.