Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-01 @ 3:16 PM
Study NCT ID:
NCT04751266
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2016-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005660', 'term': 'Funnel Chest'}], 'ancestors': [{'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, urine, tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2016-01-13', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of mean chromium values in blood (µg/l)', 'timeFrame': '4 years', 'description': "measurement of:\n\n1\\) chromium in blood (in µg/l)\n\nat the time points:\n\n1. pre implantation\n2. 4 weeks after implantation (to see change to baseline)\n3. 1 year after implantation (to see change to baseline)\n4. 2 years after implantation (to see change to baseline)\n5. explantation (usually 3 years after implantation; to see change to baseline)\n6. 6-12 months after explantation (to see change to explantation)\n\nWe 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."}, {'measure': 'change of mean chromium values in urine (µg/l)', 'timeFrame': '4 years', 'description': "measurement of: 2) chromium in urine (in µg/l)\n\nat the time points:\n\n1. pre implantation\n2. 4 weeks after implantation (to see change to baseline)\n3. 1 year after implantation (to see change to baseline)\n4. 2 years after implantation (to see change to baseline)\n5. explantation (usually 3 years after implantation; to see change to baseline)\n6. 6-12 months after explantation (to see change to explantation)\n\nWe 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."}, {'measure': 'change of mean chromium values in tissue (µg/g)', 'timeFrame': '3 years', 'description': "measurement of: 3) chromium in tissue (in µg/g)\n\nat the time points:\n\n1. implantation\n2. explantation (usually 3 years after implantation; to see change to baseline)\n\nWe 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."}, {'measure': 'change of mean nickel values in blood (µg/l)', 'timeFrame': '4 years', 'description': "measurement of: 4) nickel in blood (in µg/l)\n\nat the time points:\n\n1. pre implantation\n2. 4 weeks after implantation (to see change to baseline)\n3. 1 year after implantation (to see change to baseline)\n4. 2 years after implantation (to see change to baseline)\n5. explantation (usually 3 years after implantation; to see change to baseline)\n6. 6-12 months after explantation (to see change to explantation)\n\nWe 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."}, {'measure': 'change of mean nickel values in urine (µg/l)', 'timeFrame': '4 years', 'description': "measurement of: 5) nickel in urine (in µg/l)\n\nat the time points:\n\n1. pre implantation\n2. 4 weeks after implantation (to see change to baseline)\n3. 1 year after implantation (to see change to baseline)\n4. 2 years after implantation (to see change to baseline)\n5. explantation (usually 3 years after implantation; to see change to baseline)\n6. 6-12 months after explantation (to see change to explantation)\n\nWe 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."}, {'measure': 'change of mean nickel values in tissue (µg/g)', 'timeFrame': '3 years', 'description': "measurement of: 6) nickel in tissue (in µg/g)\n\nat the time points:\n\n1. implantation\n2. explantation (usually 3 years after implantation; to see change to baseline)\n\nWe 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."}], 'secondaryOutcomes': [{'measure': 'Observation of clinical reactions in correlation with elevated metal values', 'timeFrame': '4 years', 'description': "observation (description) of clinical symptoms of a metal allergy like\n\n* local rash\n* lassitude\n* chest pain\n* tachycardia\n* Nausea\n* pleural effusion\n\nfor the time the bar is in place (3 years) and the metal values are evaluated.\n\n-\\> Then compare the mean metal values (see above) with the baseline and the other patients (with and/or without problems)\n\nNo records when the patients don't have any problems."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Funnel Chest']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MIRPE\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04751266', 'briefTitle': 'Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Examination of Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE) and the Clinical Relevance', 'orgStudyIdInfo': {'id': '6659'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with MIRPE', 'description': 'first minimally invasive repair of pectus excavatum', 'interventionNames': ['Procedure: minimally invasive repair of pectus excavatum']}], 'interventions': [{'name': 'minimally invasive repair of pectus excavatum', 'type': 'PROCEDURE', 'description': 'substernal insertion of a metal bar', 'armGroupLabels': ['Patients with MIRPE']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Caroline Fortmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatric Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Caroline Fortmann', 'class': 'OTHER'}, 'collaborators': [{'name': 'Friedrich-Alexander-Universität Erlangen-Nürnberg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Caroline Fortmann', 'investigatorAffiliation': 'Hannover Medical School'}}}}