Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-03 @ 5:38 AM
Study NCT ID:
NCT02528656
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2015-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005660', 'term': 'Funnel Chest'}, {'id': 'D066166', 'term': 'Pectus Carinatum'}], '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'}, {'id': 'D002357', 'term': 'Cartilage Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2015-08-18', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High frequency normalized index (HFnu)', 'timeFrame': 'One month after the end of treatment', 'description': 'It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor'}], 'secondaryOutcomes': [{'measure': 'Low frequency (LF and LFnu)', 'timeFrame': 'One month after the end of treatment', 'description': 'It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.'}, {'measure': 'LF/HF ratio', 'timeFrame': 'One month after the end of treatment', 'description': 'It is another index of RR heart rate variability (HRV) measured with a ECG holter monitor.'}, {'measure': 'Blood pressure - Baroreflex', 'timeFrame': 'One month after the end of treatment', 'description': 'Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure'}, {'measure': 'Lung residual volume', 'timeFrame': 'One month after the end of treatment', 'description': 'It is expressed in litres and is measured with a plethysmograph during a pulmonary function testing.'}, {'measure': 'Maximum flow', 'timeFrame': 'One month after the end of treatment', 'description': 'It is expressed in litres per minute and is measured during a pulmonary function testing. The patient is seated and his/her nose is blocked with a clamp. He/She must blow as fast and as hard as possible.'}, {'measure': 'Aerobic maximum power', 'timeFrame': 'One month after the end of treatment', 'description': 'It is measured by a stress test (incremental exercise)'}, {'measure': 'Maximum heart rate', 'timeFrame': 'One month after the end of treatment', 'description': 'It is measured by a stress test (incremental exercise)'}, {'measure': 'Left ventricular ejection fraction', 'timeFrame': 'One month after the end of treatment', 'description': 'It is measured by an echocardiography'}, {'measure': 'Severity index of the anatomical damage', 'timeFrame': 'One month after the end of treatment', 'description': 'It is measured by a thoracic MRI. It is the ratio between the thoracic width and the distance sternum/spine.'}, {'measure': 'Nuss Questionnaire', 'timeFrame': 'One month after the end of treatment', 'description': 'It is a depression scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pectus Excavatum', 'Pectus Carinatum', 'Vacuum Bell', 'Dynamic compression system', 'Hearth variability', 'Autonomic Nervous System'], 'conditions': ['Pectus Excavatum', 'Pectus Carinatum']}, 'descriptionModule': {'briefSummary': 'The physiological assessment in non-operative treatment on chest wall deformities, are still unclear today. These functional benefits outweigh the aesthetic benefits associated with anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic, have never been evaluated.\n\nAssessment of Effects on parasympathetic activity of the autonomic nervous system, global health criterion measured by noninvasive methods.\n\nAnatomic evaluation, between the initial and final assessment by objective measures 1) of the chest wall by MRI, and 2) of the heart by echocardiography.\n\nNoninvasive physiological assessment at rest and during exercise in respiratory function exploration flows and volumes, cardiac function by flow measurement, and overall metabolic function test effort (VO2max). Subjective assessment of functional gain between the initial and final balance sheet, based on EVA scales, valued by patients, parents and doctors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with pectus excavatum or pectus carinatum who does not require surgery\n* Patient with sufficient displacement of the chest wall during an initial test carried out during the first consultation :For pectus carinatum correction must be obtained with a pressure lower than 9 psi (pound per square inch). For pectus excavatum less than 250 mbar depression.\n* Signed informed consent\n* Subject (or parents) affiliated to the French National Health Insurance\n\nExclusion Criteria:\n\n* Skeletal disease, disturbing bone strength as osteogenesis imperfect and osteoporosis.\n* Uncontrolled coagulopathies.\n* Marfan syndrome, with mitral valve prolapse for pectus Excavatum.\n* Atrial fibrillation\n* Taking antiarrhythmic drug.'}, 'identificationModule': {'nctId': 'NCT02528656', 'acronym': 'PECTUS', 'briefTitle': 'Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study', 'orgStudyIdInfo': {'id': '1408081'}, 'secondaryIdInfos': [{'id': '2014-A00841-46', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pectus Excavatum', 'description': 'Patients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device.', 'interventionNames': ['Device: Vacuum Bell']}, {'type': 'EXPERIMENTAL', 'label': 'Pectus Carinatum', 'description': 'Patients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System.', 'interventionNames': ['Device: Dynamic Compression System']}], 'interventions': [{'name': 'Vacuum Bell', 'type': 'DEVICE', 'description': 'Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.', 'armGroupLabels': ['Pectus Excavatum']}, {'name': 'Dynamic Compression System', 'type': 'DEVICE', 'description': 'Patients will be submitted to a dynamic compression system.', 'armGroupLabels': ['Pectus Carinatum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francois VARLET, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olivier TIFFET, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Frederic COSTES, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean-Claude BARTHELEMY, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arnaud PATOIR, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de SAINT-ETIENNE', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Arnaud PATOIR, MD', 'role': 'CONTACT', 'email': 'arnaud.patoir@chu-st-etienne.fr', 'phone': '(0)477828847', 'phoneExt': '+33'}, {'name': 'Arnauld GARCIN, CRA', 'role': 'CONTACT', 'email': 'arnauld.garcin@chu-st-etienne.fr', 'phone': '(0)477120286', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Manuel LOPEZ, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU de SAINT-ETIENNE'}, {'name': 'Arnaud PATOIR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'MEDICALEX', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}