Viewing Study NCT01389232

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Ignite Creation Date: 2025-12-24 @ 9:34 PM
Ignite Modification Date: 2025-12-31 @ 7:23 AM
Study NCT ID: NCT01389232
Status: COMPLETED
Last Update Posted: 2021-06-21
First Post: 2011-07-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Subjects implanted with SERI® during their Stage I breast reconstruction surgery were used to evaluate serious adverse events and adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'SeriScaffold® Surgical Scaffold', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.', 'otherNumAtRisk': 100, 'otherNumAffected': 92, 'seriousNumAtRisk': 100, 'seriousNumAffected': 53}], 'otherEvents': [{'term': 'Capsular contracture associated with breast implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Device extrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Implant site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 30}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Physical examination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 14}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Capsular contracture associated with breast implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Device extrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Mastitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Physical examination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Device Dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Medical Device Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Device Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Staphylococcal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Fractured Sacrum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Post Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Benign Breast Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'intraductal Proliferative Breast Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Invasive Ductal Breast Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Metastases to Spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Placenta Previa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Cervical Dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Pulmonary Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Skin Atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SeriScaffold® Surgical Scaffold', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a Month 6 visit. 12 subjects exited the study prior to Month 6.'}, {'type': 'SECONDARY', 'title': 'Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SeriScaffold® Surgical Scaffold', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'classes': [{'title': 'Month 3 (N=89)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (N=83)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (N=79)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (N=80)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, Month 12, Month 18, Month 24', 'description': 'Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a visit at the designated time point'}, {'type': 'SECONDARY', 'title': 'Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '100', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Ease of Use During Surgery = Very Difficult to Use', 'description': 'Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}, {'id': 'OG001', 'title': 'Ease of Use During Surgery = Difficult to Use', 'description': 'Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}, {'id': 'OG002', 'title': 'Ease of Use During Surgery = Neither Difficult Nor Easy to Use', 'description': 'Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}, {'id': 'OG003', 'title': 'Ease of Use During Surgery = Easy to Use', 'description': 'Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}, {'id': 'OG004', 'title': 'Ease of Use During Surgery = Very Easy to Use', 'description': 'Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}, {'id': 'OG005', 'title': 'Not Done', 'description': 'Implanted participants on whom procedure was reported "not done"'}], 'classes': [{'title': 'Scaffold preparation before implantation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '77', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Scaffold cutting and shaping before implantation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}]}]}, {'title': 'Scaffold positioning/drapability during implant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Scaffold cutting and shaping after implantation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Scaffold suturing during implantation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately Following Stage 1 Surgery', 'description': 'Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All implanted participants. "Scaffold cutting and sharping before implantation" was reported "Not done" on n=50'}, {'type': 'SECONDARY', 'title': 'Breast Anatomy Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}, {'units': 'Breasts', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '149', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sternal Notch to Apex', 'description': 'Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}, {'id': 'OG001', 'title': 'Sternal Notch to Inframammary Fold', 'description': 'Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}, {'id': 'OG002', 'title': 'Apex to Inframammary Fold', 'description': 'Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}, {'id': 'OG003', 'title': 'Medial Mammary Fold to Lateral Mammary Fold', 'description': 'Implanted Participants: Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'classes': [{'title': 'Preoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}, {'units': 'Breasts', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '21.7'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '23.7', 'upperLimit': '24.4'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '6.9', 'upperLimit': '7.2'}, {'value': '14.6', 'groupId': 'OG003', 'lowerLimit': '14.3', 'upperLimit': '14.9'}]}]}, {'title': 'First Postoperative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}, {'units': 'Breasts', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '133', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '19.2'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '22.3', 'upperLimit': '22.8'}, {'value': '8.1', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '8.2'}, {'value': '14.5', 'groupId': 'OG003', 'lowerLimit': '14.3', 'upperLimit': '14.8'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}, {'units': 'Breasts', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '18.8', 'upperLimit': '19.3'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '22.4', 'upperLimit': '23.0'}, {'value': '8.1', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '8.3'}, {'value': '14.2', 'groupId': 'OG003', 'lowerLimit': '14.0', 'upperLimit': '14.4'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}, {'units': 'Breasts', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '19.5'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '22.7', 'upperLimit': '23.2'}, {'value': '8.1', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '8.3'}, {'value': '14.1', 'groupId': 'OG003', 'lowerLimit': '13.8', 'upperLimit': '14.3'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}, {'units': 'Breasts', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '19.4'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '22.7', 'upperLimit': '23.3'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '8.1'}, {'value': '14.0', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '14.3'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}, {'units': 'Breasts', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '19.3'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '22.5', 'upperLimit': '23.2'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '8.1'}, {'value': '13.7', 'groupId': 'OG003', 'lowerLimit': '13.5', 'upperLimit': '14.0'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}, {'units': 'Breasts', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '19.3'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '23.2'}, {'value': '8.1', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '8.3'}, {'value': '13.8', 'groupId': 'OG003', 'lowerLimit': '13.5', 'upperLimit': '14.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24', 'description': 'Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold.', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Breasts', 'denomUnitsSelected': 'Breasts', 'populationDescription': 'All implanted breasts evaluated at the designated time point'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction With Breasts on a 5-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Breasts', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SeriScaffold® Surgical Scaffold', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'classes': [{'title': 'Baseline (Missing=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}, {'units': 'Breasts', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (Missing=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}, {'units': 'Breasts', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (Missing=1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}, {'units': 'Breasts', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 18 (Missing=2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}, {'units': 'Breasts', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 24 (Missing=0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}, {'units': 'Breasts', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24', 'description': 'Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Breasts', 'denomUnitsSelected': 'Breasts', 'populationDescription': 'All implanted breasts evaluated at the designated time point. Data was not available for 1 subject (both breasts) at baseline, 1 subject (right breast) at Month 6, 2 subjects (right breast) at Month 18 and 1 subject (right breast) at Month 24.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SeriScaffold® Surgical Scaffold', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Had scaffold removed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Enrollment was defined as having signed the IRB-approved Informed Consent Form. 104 participants were enrolled, of which 100 were implanted with SERI® Surgical Scaffold and are presented in the participant flow.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SeriScaffold® Surgical Scaffold', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.7', 'spread': '10.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects implanted with SERI® during their Stage I breast reconstruction surgery'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2014-08-22', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2011-07-06', 'dispFirstSubmitQcDate': '2014-10-03', 'resultsFirstSubmitDate': '2017-06-15', 'studyFirstSubmitQcDate': '2011-07-07', 'dispFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-25', 'studyFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale', 'timeFrame': 'Month 6', 'description': 'Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.'}], 'secondaryOutcomes': [{'measure': 'Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale', 'timeFrame': 'Month 3, Month 12, Month 18, Month 24', 'description': 'Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied.'}, {'measure': 'Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale', 'timeFrame': 'Immediately Following Stage 1 Surgery', 'description': 'Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use.'}, {'measure': 'Breast Anatomy Measurements', 'timeFrame': 'Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24', 'description': 'Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold.'}, {'measure': 'Subject Satisfaction With Breasts on a 5-Point Scale', 'timeFrame': 'Baseline, Month 6, Month 12, Month 18, Month 24', 'description': 'Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Soft Tissue Support and Repair']}, 'descriptionModule': {'briefSummary': 'This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be female, greater or equal to 18 years of age\n* Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant\n* Be willing to undergo mastectomy with healthy, well vascularized skin flaps anticipated by the surgeon\n* Be in good health other than breast pathology and be suited to general anesthesia and planned treatments\n\nExclusion Criteria:\n\n* Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study\n* Have a known allergy to silk\n* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability\n* Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation\n* Have had a prior soft tissue support device implanted in the breast\n* Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study"}, 'identificationModule': {'nctId': 'NCT01389232', 'briefTitle': 'The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sofregen Medical, Inc.'}, 'orgStudyIdInfo': {'id': 'SURE-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SeriScaffold® Surgical Scaffold', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.', 'interventionNames': ['Device: SeriScaffold® Surgical Scaffold']}], 'interventions': [{'name': 'SeriScaffold® Surgical Scaffold', 'type': 'DEVICE', 'description': 'A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair', 'armGroupLabels': ['SeriScaffold® Surgical Scaffold']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Munich', 'country': 'Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sofregen Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}