Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-29 @ 4:46 AM
Study NCT ID:
NCT05284357
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012784', 'term': 'Shoulder Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 416}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-03-08', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcomes', 'timeFrame': 'between 6 and 10 years depending on the date of implantation of the medical device in each treatment group', 'description': "Functional scores measurement with Constant-Murley's Score"}, {'measure': 'Articular functional measurement scores', 'timeFrame': 'between 6 and 10 years depending on the date of implantation of the medical device in each treatment group', 'description': 'measurement with American Shoulder and Elbow Surgeons Shoulder Score (ASES)'}, {'measure': 'subjective evaluation by the patient of shoulder function', 'timeFrame': 'between 6 and 10 years depending on the date of implantation of the medical device in each treatment group', 'description': 'Measurement with subjective shoulder value (SSV)'}], 'secondaryOutcomes': [{'measure': 'Range of Motion scores', 'timeFrame': 'between 6 and 10 years depending on the date of implantation of the medical device in each treatment group', 'description': 'Measurement of shoulder mobility (constant score)'}, {'measure': 'Revision rate', 'timeFrame': 'between 6 and 10 years depending on the date of implantation of the medical device in each treatment group', 'description': 'Number of patients with a change of implants out of the total number of patients reviewed in the study'}, {'measure': 'Rate of complication', 'timeFrame': 'between 6 and 10 years depending on the date of implantation of the medical device in each treatment group', 'description': 'All complications that had occurred will be collected in the CRF'}, {'measure': 'Last information for patient lost to follow-up', 'timeFrame': 'between 6 and 10 years depending on the date of implantation of the medical device in each treatment group', 'description': 'All available information about patients during his last medical follow-up'}, {'measure': 'Survival rate', 'timeFrame': 'between 6 and 10 years depending on the date of implantation of the medical device in each treatment group', 'description': 'Kaplan-Meier curve'}, {'measure': 'Last information for deceased patient', 'timeFrame': 'between 6 and 10 years depending on the date of implantation of the medical device in each treatment group', 'description': 'All available information about patients before his death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Shoulder Disease', 'Shoulder Fractures', 'Shoulder Arthroplasty for Revision of Previous Treatment']}, 'referencesModule': {'references': [{'pmid': '25027481', 'type': 'BACKGROUND', 'citation': 'Churchill RS. Stemless shoulder arthroplasty: current status. J Shoulder Elbow Surg. 2014 Sep;23(9):1409-14. doi: 10.1016/j.jse.2014.05.005. Epub 2014 Jul 11.'}, {'pmid': '18519317', 'type': 'BACKGROUND', 'citation': 'Cuff D, Pupello D, Virani N, Levy J, Frankle M. Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency. J Bone Joint Surg Am. 2008 Jun;90(6):1244-51. doi: 10.2106/JBJS.G.00775.'}, {'pmid': '15475201', 'type': 'BACKGROUND', 'citation': 'De Wilde LF, Audenaert EA, Berghs BM. Shoulder prostheses treating cuff tear arthropathy: a comparative biomechanical study. J Orthop Res. 2004 Nov;22(6):1222-30. doi: 10.1016/j.orthres.2004.03.010.'}, {'pmid': '16951091', 'type': 'BACKGROUND', 'citation': 'Frankle M, Levy JC, Pupello D, Siegal S, Saleem A, Mighell M, Vasey M. The reverse shoulder prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. a minimum two-year follow-up study of sixty patients surgical technique. J Bone Joint Surg Am. 2006 Sep;88 Suppl 1 Pt 2:178-90. doi: 10.2106/JBJS.F.00123.'}, {'pmid': '3361319', 'type': 'BACKGROUND', 'citation': 'Franklin JL, Barrett WP, Jackins SE, Matsen FA 3rd. Glenoid loosening in total shoulder arthroplasty. Association with rotator cuff deficiency. J Arthroplasty. 1988;3(1):39-46. doi: 10.1016/s0883-5403(88)80051-2.'}, {'pmid': '28410956', 'type': 'BACKGROUND', 'citation': 'Hawi N, Magosch P, Tauber M, Lichtenberg S, Habermeyer P. Nine-year outcome after anatomic stemless shoulder prosthesis: clinical and radiologic results. J Shoulder Elbow Surg. 2017 Sep;26(9):1609-1615. doi: 10.1016/j.jse.2017.02.017. Epub 2017 Apr 11.'}, {'pmid': '27577859', 'type': 'BACKGROUND', 'citation': 'Hawi N, Tauber M, Messina MJ, Habermeyer P, Martetschlager F. Anatomic stemless shoulder arthroplasty and related outcomes: a systematic review. BMC Musculoskelet Disord. 2016 Aug 30;17(1):376. doi: 10.1186/s12891-016-1235-0.'}, {'pmid': '21332439', 'type': 'BACKGROUND', 'citation': 'Jazayeri R, Kwon YW. Evolution of the reverse total shoulder prosthesis. Bull NYU Hosp Jt Dis. 2011;69(1):50-5.'}, {'pmid': '357063', 'type': 'BACKGROUND', 'citation': 'Lugli T. Artificial shoulder joint by Pean (1893): the facts of an exceptional intervention and the prosthetic method. Clin Orthop Relat Res. 1978 Jun;(133):215-8.'}, {'pmid': '14367414', 'type': 'BACKGROUND', 'citation': 'NEER CS 2nd. Articular replacement for the humeral head. J Bone Joint Surg Am. 1955 Apr;37-A(2):215-28. No abstract available.'}, {'pmid': '6654936', 'type': 'BACKGROUND', 'citation': 'Neer CS 2nd, Craig EV, Fukuda H. Cuff-tear arthropathy. J Bone Joint Surg Am. 1983 Dec;65(9):1232-44.'}, {'pmid': '7061549', 'type': 'BACKGROUND', 'citation': 'Neer CS 2nd, Watson KC, Stanton FJ. Recent experience in total shoulder replacement. J Bone Joint Surg Am. 1982 Mar;64(3):319-37. No abstract available.'}, {'pmid': '535215', 'type': 'BACKGROUND', 'citation': 'Post M, Jablon M, Miller H, Singh M. Constrained total shoulder joint replacement: a critical review. Clin Orthop Relat Res. 1979 Oct;(144):135-50.'}]}, 'descriptionModule': {'briefSummary': "This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a long term and mainly the first two years of sales for each studied ranges.\n\nEligible patients who received the FX Solutions Shoulder System and are at about 7 years post-operative were contacted by the Investigator to explain the study, the retrospective collection and the prospective follow-up visit. Investigator also explain the analysis of the post-operative outcomes of the patient. During the call of the investigator, the patient was informed about the study's goal and about the data collection. The oral agreement of the patient was checked by the investigators in CRF with its signature. Then, an information form explaining the purpose of the data collection was provided to the patient by postmail.\n\nThe retrospective data were collected in a paper CRF via the medical file of patient.\n\nPost-operative follow-up for all patients is limited to a teleconsultation intended to assess the patient's current condition and clinical outcomes.\n\nPatient who are enrolled in the study shall be assigned a unique Subject Identification Number to de-identify their information.", 'detailedDescription': 'Inclusion Criteria\n\n* Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement.\n* Patient implanted between 2011 and 2015 with a minimum follow-up of 7 years\n* Patient has been informed of his participation in a clinical study and did not object to data collection\n* Patient insured with a social security system\n\nExclusion Criteria\n\n* Patient who does not meet the inclusion criteria above\n* Protected adult\n* People deprived of their liberty\n\nStudy Objectives\n\n* Primary Objective: To assess functional improvement according to the Constant score evolution compared to its preoperative value\n* Secondary Objectives, assessment of:\n\nTo assess against the preoperative value:\n\n* the Subjective Shoulder Value score evolution\n* the American Shoulder and Elbow Surgeons shoulder score evolution To describe in real life\n* The complications rate\n* The long-term range of motion\n* The revision rates and the prosthesis survival curve\n\nEndpoints\n\n* Primary Endpoint will be the current Constant score (measured during the assessment). The functional improvement will be evaluated according to the evolution of this score compared to its preoperative value.\n* Secondary Endpoints:\n\nCurrent ASES and SSV scores Current range of Motion Revision rate at a long-term follow-up. Calculation of the survival rates The incidence of complications occurring since implantation Revision rates and survival rates of prostheses\n\nStudy Groups Group 1: Subjects implanted with HUMELOCK I \\& II® Anatomic Shoulder System 2011 to 2013 Group 2: Subjects implanted with HUMELOCK II® Reversible System 2011 to 2013 Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System - 2012 - 2013 Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System - 2013 - 2014 Group 5: Subjects implanted with EASYTECH® Reversed Shoulder System (For Primary intention only) - 2013- 2014 Group 6: additional group for Subjects who were implanted with EASYTECH® Reversible Shoulder System (Exclusively for Revision of Easytech Anatomic) - 2013 -2014, if applicable Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System 2014 to 2015 Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System 2014 to 2015'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Studied devices are intended for adult population that are treated for arthroplasty with the studied devices. These patients are presented a pathologic shoulder pain with origin with degeneration or trauma of the articulation pathologies.\n\nThis study will include adult male and female patients from the Investigators' practice who were implanted with the FX Solution System; inclusion and exclusion criteria are defined not to introduce a too important bias of selection.\n\nThe selected patients may be representative the overall population that could treated with devices.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFirst of all, in order to be eligible to the study protocol, patients should have been treated primarily with one of studied device depending on surgeons' strategies' cares.\n\nIn order to be eligible to participate in this study, patients must meet all of the following criteria:\n\n* Adult patient (≥ 18 years old) who received one of FX Solutions Shoulder System for indication of hemi or total shoulder replacement.\n* Patient implanted between 2011 and 2015 with a minimum follow-up of 7 years\n* Patient has been informed of his participation in a clinical study and did not object to data collection\n* Patient insured with a social security system\n\nExclusion criteria for subject selection.\n\n* Patient who does not meet the inclusion criteria above\n* Protected adult\n* People deprived of their liberty"}, 'identificationModule': {'nctId': 'NCT05284357', 'briefTitle': 'Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term', 'organization': {'class': 'INDUSTRY', 'fullName': 'FX Solutions'}, 'officialTitle': 'Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term Retro-Prospective, Non-Randomized, Non-Interventional Study', 'orgStudyIdInfo': {'id': 'FX_PROTOC_CL_21-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System', 'description': "The number of patients implanted was defined by comparing sales' database of FX Solutions.\n\n97 patients were identified who could be included in this cohort in 11 investigational centers.\n\nsubjects implanted in 2011 to 2013", 'interventionNames': ['Device: Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System']}, {'label': 'Group 2: Subjects implanted with HUMELOCK II® Reversible System', 'description': "The number of patients implanted was defined by comparing sales' database of FX Solutions.\n\nNumber of patient to be determined following patients files in 4 investigational centers.\n\nsubjects implanted in 2011 to 2013", 'interventionNames': ['Device: Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System']}, {'label': 'Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System', 'description': "The number of patients implanted was defined by comparing sales' database of FX Solutions.\n\n154 patients were identified who could be included in this cohort in 5 investigational centers.\n\nsubjects implanted in 2012 and 2013", 'interventionNames': ['Device: Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System']}, {'label': 'Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System', 'description': "The number of patients implanted was defined by comparing sales' database of FX Solutions.\n\n66 patients were identified who could be included in this cohort in 5 investigational centers subjects implanted in 2013 and 2014", 'interventionNames': ['Device: Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder System']}, {'label': 'Group 5: Subjects implanted with EASYTECH® Reversed System (Primary intention)', 'description': "The number of patients implanted was defined by comparing sales' database of FX Solutions.\n\n7 patients were identified who could be included in this cohort in 5 investigational centers subjects implanted in 2013 and 2014", 'interventionNames': ['Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention)']}, {'label': 'Group 6:Subjects implanted with EASYTECH® Reversible System (Revision of Easytech Anatomic)', 'description': "The number of patients implanted was defined by comparing sales' database of FX Solutions.\n\nthe number of subjects will depend of revised subjects primary implanted with Easytech Anatomic® along the dedicated period subjects implanted in 2013 to 2014", 'interventionNames': ['Device: Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only)']}, {'label': 'Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System', 'description': "The number of patients implanted was defined by comparing sales' database of FX Solutions.\n\n11 patients were identified who could be included in this cohort in 3 investigational centers Subjects implanted in 2014 to 2015", 'interventionNames': ['Device: Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder System']}, {'label': 'Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System', 'description': "The number of patients implanted was defined by comparing sales' database of FX Solutions.\n\n72 patients were identified who could be included in this cohort in 2 investigational centers Subjects implanted in 2014 to 2015", 'interventionNames': ['Device: Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder System']}], 'interventions': [{'name': 'Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System', 'type': 'DEVICE', 'description': "HUMELOCK II® is a new-generation of modular implant designed for the effective treatment of 3 or 4 part fractures of proximal humerus. The range of cases in which it can be used is wider than a simple reconstructive anatomical prosthesis. In fact, thanks to its anchoring plate, and if cephalic perfusion criteria are met, the modular nature of HUMELOCK II® means it is possible to retain the patient's native humeral head, even in cases of severe osteopenia.\n\nThe HUMELOCK II® shoulder prosthesis allows the reconstruction of the shoulder joint as a result of a trauma (complex fracture of the proximal humerus, a common occurrence in severely injured shoulders. The HUMELOCK II® shoulder system may also be suitable for treating cases of failure of an existing shoulder prosthesis where a stem or other locking mechanism may be needed. The HUMELOCK II® shoulder prosthesis is a hemi shoulder and a total shoulder prosthesis.", 'armGroupLabels': ['Group 1: Subjects implanted with HUMELOCK I & II® Anatomic Shoulder System']}, {'name': 'Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System', 'type': 'DEVICE', 'description': 'HUMELOCK II® is a new-generation of modular implant designed for the effective treatment of 3 or 4 part fractures of proximal humerus.\n\nThe HUMELOCK II® shoulder prosthesis allows the reconstruction of the shoulder joint as a result of a trauma (complex fracture of the proximal humerus). It is designed for use in complex shoulder reconstruction procedures in patients with stage 3 or 4 fragments in the proximal humerus - a common occurrence in severely injured shoulders. The HUMELOCK II® reversible system may also be suitable for treating cases of failure of an existing shoulder prosthesis where a stem or other locking mechanism may be needed.\n\nThe HUMELOCK II reversible system is used when the rotator cuff is injured.', 'armGroupLabels': ['Group 2: Subjects implanted with HUMELOCK II® Reversible System']}, {'name': 'Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System', 'type': 'DEVICE', 'description': "Humelock Reversed® is a new generation of reversed prosthesis, designed for numerous shoulder pathologies: ranging from offset arthritis to a complex cephalotuberosity fracture. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post and the position of which is guided by an intuitive adaptive instrumentation. A 145° prosthetic epiphysis allows the pillar of the scapula to be protected while maintaining optimum stability. The humeral implant is positioned naturally in the center of the epiphysis, preserving the remaining bone as much as possible. Options of locking or cementing will allow the surgeon to position the prosthetic stem at the required height, according to the patient's indication and anatomy. The surgery is called total shoulder arthroplasty. It is also indicated in a failed hemi-arthroplasty or a failed total arthroplasty. It is indicated for significant rupture of rotator cuff-tear (first surgery or revision surgery)", 'armGroupLabels': ['Group 3: Subjects implanted with HUMELOCK Reversed® Shoulder System']}, {'name': 'Shoulder Arthroplasty Surgery with EASYTECH® Anatomic Shoulder System', 'type': 'DEVICE', 'description': 'EASYTECH Anatomical Shoulder System is indicated for use in total shoulder replacement to treat a severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis.\n\nEASYTECH system is a new generation of modular implant designed for the reconstruction of the shoulder joint for treating cases of degenerative pathology. The surgery is called total shoulder arthroplasty. EASYTECH prosthesis is a stemless system of shoulder components. It is a bone-preserving implant. The anchor base provides primary stability to pulling-out thanks to peripheral pegs in the shape of fir trees and their asymmetric orientations ensure its rotational stability', 'armGroupLabels': ['Group 4: Subjects implanted with EASYTECH® Anatomic Shoulder System']}, {'name': 'Shoulder Arthroplasty Surgery with EASYTECH® Reversed System (Primary intention)', 'type': 'DEVICE', 'description': 'EASYTECH Reversed Shoulder System is indicated for primary total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.\n\nEASYTECH system is a new generation of modular implant designed for the reconstruction of the shoulder joint for treating cases of degenerative pathology. . EASYTECH prosthesis is a stemless system of shoulder components. It is a bone-preserving implant. The anchor base provides primary stability to pulling-out thanks to peripheral pegs in the shape of fir trees and their asymmetric orientations ensure its rotational stability. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post (compatible with positioning techniques), and the position of which is guided by an intuitive adaptive instrumentation', 'armGroupLabels': ['Group 5: Subjects implanted with EASYTECH® Reversed System (Primary intention)']}, {'name': 'Shoulder Arthroplasty Surgery with EASYTECH® Reversible System (for revision only)', 'type': 'DEVICE', 'description': 'EASYTECH Reversible Shoulder System is indicated for revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.\n\nEASYTECH system is a new generation of modular implant designed for the reconstruction of the shoulder joint for treating cases of degenerative pathology. . EASYTECH prosthesis is a stemless system of shoulder components. It is a bone-preserving implant. The anchor base provides primary stability to pulling-out thanks to peripheral pegs in the shape of fir trees and their asymmetric orientations ensure its rotational stability. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post (compatible with positioning techniques), and the position of which is guided by an intuitive adaptive instrumentation.', 'armGroupLabels': ['Group 6:Subjects implanted with EASYTECH® Reversible System (Revision of Easytech Anatomic)']}, {'name': 'Shoulder Arthroplasty Surgery with HUMERIS® Anatomic Shoulder System', 'type': 'DEVICE', 'description': 'The HUMERIS Shoulder system is intended to be used in adult patients with glenohumeral joint degenerative pathologies associated or not with rotator cuff arthropathy or tears when all other non-invasive treatments have failed to reduce the pain or improve the quality of life. The HUMERIS shoulder is a system of short stem.The technical characteristics of this implant have been designed based on computer simulations, correlated to results previously published in medical journals. A 145° prosthetic epiphysis allows the pillar of the scapula to be protected while maintaining optimum stability. The humeral implant is positioned naturally in the center of the epiphysis, preserving the remaining bone as much as possible.', 'armGroupLabels': ['Group 7: Subjects implanted with HUMERIS® Anatomic Shoulder System']}, {'name': 'Shoulder Arthroplasty Surgery with HUMERIS® Reversible Shoulder System', 'type': 'DEVICE', 'description': 'The HUMERIS Shoulder system is intended to be used in adult patients with glenohumeral joint degenerative pathologies associated or not with rotator cuff arthropathy or tears when all other non-invasive treatments have failed to reduce the pain or improve the quality of life. The HUMERIS shoulder is a system of short stem.The technical characteristics of this implant have been designed based on computer simulations, correlated to results previously published in medical journals, in order to avoid the disadvantages of traditional reverse prostheses. A centric or eccentric glenosphere, tilted at 10°, centered on a variable length baseplate post, the position of which is guided by an intuitive adaptive instrumentation.A 145° prosthetic epiphysis allows the pillar of the scapula to be protected while maintaining optimum stability.The humeral implant is positioned naturally in the center of the epiphysis, preserving the remaining bone as much as possible', 'armGroupLabels': ['Group 8: Subjects implanted with HUMERIS® Reversible Shoulder System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92160', 'city': 'Antony', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Edouard DECRETTE, MD', 'role': 'CONTACT', 'email': 'decrette.edouard@gmail.com', 'phone': '+33 1 81 80 22 51'}, {'name': 'Edouard DECRETTE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Privé Antony', 'geoPoint': {'lat': 48.75329, 'lon': 2.29668}}, {'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent OBERT, MD', 'role': 'CONTACT', 'email': 'lobert@chu-besancon.fr', 'phone': '+33 3 81 66 82 85'}, {'name': 'Laurent OBERT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Jean MINJOZ', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '01000', 'city': 'Bourg-en-Bresse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Samuel FERRY, MD', 'role': 'CONTACT', 'email': 'sferry@ch-bourg01.fr', 'phone': '+33 4 74 45 46 47'}, {'name': 'Samuel FERRY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre hospitalier Bourg en Bresse', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '01000', 'city': 'Bourg-en-Bresse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal CLAPPAZ, MD', 'role': 'CONTACT', 'email': 'clappaz@ymail.com', 'phone': '+33 4 74 45 64 03'}, {'name': 'Pascal CLAPPAZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Convert', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '69300', 'city': 'Caluire-et-Cuire', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry AUTHOM, MD', 'role': 'CONTACT', 'email': 'thierry.authom@infirmerie-protestante.com', 'phone': '+33 4.72.00.71.60'}, {'name': 'Thierry AUTHOM, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Infirmerie Protestante', 'geoPoint': {'lat': 45.79462, 'lon': 4.8464}}, {'zip': '71110', 'city': 'Chalon-sur-Saône', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hugues DELASELLE, MD', 'role': 'CONTACT', 'email': 'h.delaselle@ramsaygds.fr', 'phone': '+33 3.85.97.81.91'}, {'name': 'Hugues DELASELLE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital privé Sainte Marie', 'geoPoint': {'lat': 46.78112, 'lon': 4.85372}}, {'zip': '73011', 'city': 'Chambéry', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel BEAUDOUIN, MD', 'role': 'CONTACT', 'email': 'Emmanuel.Beaudouin@ch-metropole-savoie.fr', 'phone': '+33 4.79.96.51.44'}, {'name': 'Emmanuel BEAUDOUIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHMS Chambéry', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '92400', 'city': 'Courbevoie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc JUVENSPAN, MD', 'role': 'CONTACT', 'email': 'm.juvenspan@gmail.com', 'phone': '+33 1 86 86 56 56'}, {'name': 'Marc JUVENSPAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique La Montagne', 'geoPoint': {'lat': 48.89672, 'lon': 2.25666}}, {'zip': '7620', 'city': 'Dieppe', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire Cordier, MD', 'role': 'CONTACT', 'email': 'ccfuzeau@gmail.com', 'phone': '+33 2 32 14 76 76'}, {'name': 'Claire Cordier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Dieppe', 'geoPoint': {'lat': 49.9216, 'lon': 1.07772}}, {'zip': '27000', 'city': 'Évreux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Edouard DECRETTE, MD', 'role': 'CONTACT', 'email': 'cabinet.edouarddecrette@gmail.com', 'phone': '+33 2 32 60 00 59'}, {'name': 'Edouard DECRETTE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Bergouignan', 'geoPoint': {'lat': 49.02414, 'lon': 1.15082}}, {'zip': '69001', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thierry AUTHOM, MD', 'role': 'CONTACT', 'email': 'thauthom@gmail.com', 'phone': '+33 4 26 84 20 23'}, {'name': 'Thierry AUTHOM, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Saint Charles', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '31600', 'city': 'Muret', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves Bellumore, MD', 'role': 'CONTACT', 'email': 'Bellumore.y@orange.fr', 'phone': '+33 5 61 51 89 09'}, {'name': 'Yves Bellumore, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Clinique de l'Occitanie", 'geoPoint': {'lat': 43.45998, 'lon': 1.32541}}, {'zip': '75016', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Éric LENOBLE, MD', 'role': 'CONTACT', 'email': 'e.lenoble@ramsaygds.mssante.fr', 'phone': '+33 1.42.15.42.10'}, {'name': 'Eric LENOBLE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Jouvenet', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Geoffroy NOURISSAT, MD', 'role': 'CONTACT', 'email': 'gnourissat@wanadoo.fr', 'phone': '+33 1 42 03 47 37'}, {'name': 'Geoffroy NOURISSAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique des Maussins', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '78300', 'city': 'Poissy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nacer DEBIT, MD', 'role': 'CONTACT', 'email': 'nacer.debit@ght-yvelinesnord.fr', 'phone': '+33 1.39.27.51.72'}, {'name': 'Nacer DEBIT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHI Poissy - St Germain en Laye', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}, {'zip': '91480', 'city': 'Quincy-sous-Sénart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Éric LENOBLE, MD', 'role': 'CONTACT', 'email': 'eric.lenoble@wanadoo.fr', 'phone': '+33 1 69 39 91 46'}, {'name': 'Éric LENOBLE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Privé Claude Gallien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}, {'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tewfik Benkalfate, MD', 'role': 'CONTACT', 'email': 'tewfik.benkalfate@hospigrandouest.fr', 'phone': '+33 2 99 85 75 75'}, {'name': 'Tewfik Benkalfate, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Mutualiste la Sagesse', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '35400', 'city': 'St-Malo', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arthur Veil-Picard, MD', 'role': 'CONTACT', 'email': 'arthur.veilpicard@gmail.com', 'phone': '+33 2 99 21 21 21'}, {'name': 'Arthur Veil-Picard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de St Malo', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'zip': '49800', 'city': 'Trélazé', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hassan WAHAB, MD', 'role': 'CONTACT', 'email': 'hassan.wahab@villagesante.fr', 'phone': '+33 2 41 41 73 60'}, {'name': 'Antoine GOURNAY, MD', 'role': 'CONTACT', 'email': 'antoine.gournay@villagesante.fr', 'phone': '+33 2.41.41.73.49'}, {'name': 'Hassan WAHAB, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antoine GOURNAY, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinique Saint Léonard', 'geoPoint': {'lat': 47.44629, 'lon': -0.46652}}, {'zip': '98000', 'city': 'Monaco', 'status': 'RECRUITING', 'country': 'Monaco', 'contacts': [{'name': 'Tristan LASCAR, MD', 'role': 'CONTACT', 'email': 'tristan.lascar@chpg.mc', 'phone': '+377 97 98 97 14'}, {'name': 'Tristan LASCAR, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Princesse Grace', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}], 'centralContacts': [{'name': 'Cédric FERRY', 'role': 'CONTACT', 'email': 'clinique@fxsolutions.fr', 'phone': '+33 6 09 25 13 13'}, {'name': 'Carole CARRÉ', 'role': 'CONTACT', 'email': 'clinique@fxsolutions.fr', 'phone': '+33 6 09 25 38 08'}], 'overallOfficials': [{'name': 'Laurent OBERT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Jean MINJOZ'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IDP for this study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FX Solutions', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}