Congenital Funnel ChestNCT04751266
Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)
An observational study of Congenital Funnel Chest, run by Dr. Caroline Fortmann.
Trial summary
The purpose of this study is to determine whether there is a metal wear debris after minimally invasive repair of pectus excavatum and if there's a clinical relevance. Our hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to a locally and systemic immune reaction due to… Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Congenital Funnel Chest
- What is being tested?
- minimally invasive repair of pectus excavatum
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2022
- 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: primary care clinic
Who may be able to join
- MIRPE
Who cannot join
- none
About this study
Official title: Examination of Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE) and the Clinical Relevance
The purpose of this study is to determine whether there is a metal wear debris after minimally invasive repair of pectus excavatum and if there's a clinical relevance. Our hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to a locally and systemic immune reaction due to elevated metal contamination.
- Conditions
- Congenital Funnel Chest
- Being tested
- minimally invasive repair of pectus excavatum
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive repair of pectus excavatumProcedure or surgery
substernal insertion of a metal bar
| Study group | Role | What they receive |
|---|---|---|
| Patients with MIRPE | first minimally invasive repair of pectus excavatum Receives: Procedure: minimally invasive repair of pectus excavatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of mean chromium values in blood (µg/l)
measurement of:
- chromium in blood (in µg/l) at the time points:
- pre implantation
- 4 weeks after implantation (to see change to baseline)
- 1 year after implantation (to see change to baseline)
- 2 years after implantation (to see change to baseline)
- explantation (usually 3 years after implantation; to see change to baseline)
- 6-12 months after explantation (to see change to explantation)
We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
Measured: 4 years
change of mean chromium values in urine (µg/l)
measurement of: 2) chromium in urine (in µg/l)
at the time points:
- pre implantation
- 4 weeks after implantation (to see change to baseline)
- 1 year after implantation (to see change to baseline)
- 2 years after implantation (to see change to baseline)
- explantation (usually 3 years after implantation; to see change to baseline)
- 6-12 months after explantation (to see change to explantation)
We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
Measured: 4 years
change of mean chromium values in tissue (µg/g)
measurement of: 3) chromium in tissue (in µg/g)
at the time points:
- implantation
- explantation (usually 3 years after implantation; to see change to baseline)
We will compare the mean metal values at explantation with the mean metal values before implantation. Clinical data like body weight etc. won't be relevant for the analysis.
Measured: 3 years
change of mean nickel values in blood (µg/l)
measurement of: 4) nickel in blood (in µg/l)
at the time points:
- pre implantation
- 4 weeks after implantation (to see change to baseline)
- 1 year after implantation (to see change to baseline)
- 2 years after implantation (to see change to baseline)
- explantation (usually 3 years after implantation; to see change to baseline)
- 6-12 months after explantation (to see change to explantation)
We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
Measured: 4 years
change of mean nickel values in urine (µg/l)
measurement of: 5) nickel in urine (in µg/l)
at the time points:
- pre implantation
- 4 weeks after implantation (to see change to baseline)
- 1 year after implantation (to see change to baseline)
- 2 years after implantation (to see change to baseline)
- explantation (usually 3 years after implantation; to see change to baseline)
- 6-12 months after explantation (to see change to explantation)
We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
Measured: 4 years
change of mean nickel values in tissue (µg/g)
measurement of: 6) nickel in tissue (in µg/g)
at the time points:
- implantation
- explantation (usually 3 years after implantation; to see change to baseline)
We will compare the mean metal values at explantation with the mean metal values before implantation. Clinical data like body weight etc. won't be relevant for the analysis.
Measured: 3 years
Secondary outcomes (1)
Observation of clinical reactions in correlation with elevated metal values
observation (description) of clinical symptoms of a metal allergy like
- local rash
- lassitude
- chest pain
- tachycardia
- Nausea
- pleural effusion for the time the bar is in place (3 years) and the metal values are evaluated.
-> Then compare the mean metal values (see above) with the baseline and the other patients (with and/or without problems)
No records when the patients don't have any problems.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study startMar 2015
- Primary completionApr 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Funnel ChestStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Caroline Fortmann
- Sponsor type
- University, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Responsible party
- Sponsor-investigator, Dr. Caroline Fortmann, Hannover Medical School
- Investigators
- Caroline Fortmann, MD, Principal investigator, Department of Pediatric Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751266
- Sponsor's protocol ID
- 6659
- Status last verified
- Apr 2022
- First submitted
- 13 Jan 2016
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE) and the Clinical Relevance
- ClinicalTrials.gov ID
- NCT04751266
- Acronym / sponsor ID
- 6659
- Conditions
- Congenital Funnel Chest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dr. Caroline FortmannUniversity, hospital or other
- Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Study start
- Mar 2015
- Primary completion
- Apr 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 12 Feb 2021 (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.
The purpose of this study is to determine whether there is a metal wear debris after minimally invasive repair of pectus excavatum and if there's a clinical relevance. Our hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to a locally and systemic immune reaction due to elevated metal contamination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with MIRPE | – | Procedure: minimally invasive repair of pectus excavatumfirst minimally invasive repair of pectus excavatum |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- MIRPE
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive repair of pectus excavatumsubsternal insertion of a metal bar | Procedure or surgery | Patients with MIRPE |
Primary outcome
change of mean chromium values in blood (µg/l)
Time frame: 4 years
measurement of: 1) chromium in blood (in µg/l) at the time points: 1. pre implantation 2. 4 weeks after implantation (to see change to baseline) 3. 1 year after implantation (to see change to baseline) 4. 2 years after implantation (to see change to baseline) 5. explantation (usually 3 years after implantation; to see change to baseline) 6. 6-12 months after explantation (to see change to explantation) We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean chromium values in urine (µg/l)
Time frame: 4 years
measurement of: 2) chromium in urine (in µg/l) at the time points: 1. pre implantation 2. 4 weeks after implantation (to see change to baseline) 3. 1 year after implantation (to see change to baseline) 4. 2 years after implantation (to see change to baseline) 5. explantation (usually 3 years after implantation; to see change to baseline) 6. 6-12 months after explantation (to see change to explantation) We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean chromium values in tissue (µg/g)
Time frame: 3 years
measurement of: 3) chromium in tissue (in µg/g) at the time points: 1. implantation 2. explantation (usually 3 years after implantation; to see change to baseline) We will compare the mean metal values at explantation with the mean metal values before implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean nickel values in blood (µg/l)
Time frame: 4 years
measurement of: 4) nickel in blood (in µg/l) at the time points: 1. pre implantation 2. 4 weeks after implantation (to see change to baseline) 3. 1 year after implantation (to see change to baseline) 4. 2 years after implantation (to see change to baseline) 5. explantation (usually 3 years after implantation; to see change to baseline) 6. 6-12 months after explantation (to see change to explantation) We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean nickel values in urine (µg/l)
Time frame: 4 years
measurement of: 5) nickel in urine (in µg/l) at the time points: 1. pre implantation 2. 4 weeks after implantation (to see change to baseline) 3. 1 year after implantation (to see change to baseline) 4. 2 years after implantation (to see change to baseline) 5. explantation (usually 3 years after implantation; to see change to baseline) 6. 6-12 months after explantation (to see change to explantation) We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean nickel values in tissue (µg/g)
Time frame: 3 years
measurement of: 6) nickel in tissue (in µg/g) at the time points: 1. implantation 2. explantation (usually 3 years after implantation; to see change to baseline) We will compare the mean metal values at explantation with the mean metal values before implantation. Clinical data like body weight etc. won't be relevant for the analysis.
1 secondary outcome
Observation of clinical reactions in correlation with elevated metal values
Time frame: 4 years
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 19 Apr 2022.
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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.
Caroline Fortmann, MD principal investigator
Department of Pediatric Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Funnel Chest, run by Dr. Caroline Fortmann.
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 1 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
change of mean chromium values in blood (µg/l) (time frame: 4 years). The study lists 6 primary outcomes in all. 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 19 Apr 2022.