Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)

NCT ID: NCT04751266

Last Updated: 2022-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Funnel Chest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with MIRPE

first minimally invasive repair of pectus excavatum

minimally invasive repair of pectus excavatum

Intervention Type PROCEDURE

substernal insertion of a metal bar

Interventions

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minimally invasive repair of pectus excavatum

substernal insertion of a metal bar

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* MIRPE

Exclusion Criteria

* none
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Friedrich-Alexander-Universität Erlangen-Nürnberg

OTHER

Sponsor Role collaborator

Dr. Caroline Fortmann

OTHER

Sponsor Role lead

Responsible Party

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Dr. Caroline Fortmann

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Caroline Fortmann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatric Surgery

Other Identifiers

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6659

Identifier Type: -

Identifier Source: org_study_id

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