Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT01256502
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2010-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
Sponsor:
Organization:
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': 'As this study involves multiple centers, no individual publications will be allowed prior to completion of the final report of the multicenter study except as agreed with Allergan.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'None to report.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 months following SERI implantation', 'description': 'All Serious Adverse Events (SAEs) are reported. All Adverse Events (AEs) occurring at \\>5% frequency are reported. Individual participants can experience more than 1 AE.', 'eventGroups': [{'id': 'EG000', 'title': 'Implanted Participants', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.', 'otherNumAtRisk': 139, 'otherNumAffected': 107, 'seriousNumAtRisk': 139, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Capsular contracture associated with breast implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lobular breast carcinoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Deep vein thrombosis', 'notes': 'This event was classified as unrelated to the SERI® surgical scaffold but related to the surgical procedure. The subject was treated with antihistamines and anticoagulants. The event was reported as serious and ongoing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vaginal cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vaginal ulceration', 'notes': 'This event was classified as unrelated to the SERI® surgical scaffold or the procedure and resolved without sequelae after treatment with antipruritics and antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Salivary gland calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Metastases to spleen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pancreatic carcinoma metastatic', 'notes': 'This event was classified as unrelated to the SERI® surgical scaffold or the procedure. This event remains ongoing.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pericarditis constrictive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Capsular contracture associated with breast implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Implant site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Mastitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Participants', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '0.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 139 participants, 214 breasts, implanted with SERI® during Stage I breast reconstruction, 4 discontinued the study and 1 missed the 6-month visit, leaving 134 subjects, 205 breasts in the primary analysis population.'}, {'type': 'SECONDARY', 'title': 'Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '139', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Very Difficult to Use'}, {'id': 'OG001', 'title': 'Difficult to Use'}, {'id': 'OG002', 'title': 'Neither Difficult Nor Easy to Use'}, {'id': 'OG003', 'title': 'Easy to Use'}, {'id': 'OG004', 'title': 'Very Easy to Use'}], 'classes': [{'title': 'SERI® preparation before implantation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}]}]}, {'title': 'SERI® cutting and shaping before implantation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '121', 'groupId': 'OG004'}]}]}, {'title': 'SERI® positioning/drapability during implantation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}]}]}, {'title': 'SERI® cutting and shaping after implantation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}]}]}, {'title': 'SERI® suturing during implantation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately following Stage I surgery', 'description': 'Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis population included all enrolled participants who had SERI® Placement during Stage I Surgery.'}, {'type': 'SECONDARY', 'title': 'Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted Participants', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'classes': [{'title': 'Stage 2 Surgery (n=202 breasts)', 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.25', 'groupId': 'OG000', 'lowerLimit': '9.06', 'upperLimit': '9.47'}]}]}, {'title': 'Month 12 (n=198 breasts)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '0.89', 'groupId': 'OG000', 'lowerLimit': '9.34', 'upperLimit': '9.62'}]}]}, {'title': 'Month 18 (n=199 breasts)', 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.26', 'groupId': 'OG000', 'lowerLimit': '9.13', 'upperLimit': '9.56'}]}]}, {'title': 'Month 24 (n=195 breasts)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '1.01', 'groupId': 'OG000', 'lowerLimit': '9.41', 'upperLimit': '9.72'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Stage 2 Surgery, Months 12, 18 and 24', 'description': 'Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Full Analysis population (139 participants, 214 breasts), all enrolled participants who had SERI® Surgical Scaffold surgery/implant, with data at the given time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Implanted Participants', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Implanted with SERI during Stage I breast reconstruction surgery', 'groupId': 'FG000', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Had scaffold removed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Enrollment was defined as having signed the IRB-approved Informed Consent Form. 160 patients were enrolled, of which 139 were implanted with SERI® Surgical Scaffold.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Implanted Participants', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 19 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '20 to 29 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '30 to 39 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': '40 to 49 years', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': '50 to 59 years', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': '60 to 69 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': '70+ years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '139', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', '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': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-05', 'studyFirstSubmitDate': '2010-12-07', 'resultsFirstSubmitDate': '2013-12-18', 'studyFirstSubmitQcDate': '2010-12-07', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-16', 'studyFirstPostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months', 'timeFrame': '6 months', 'description': 'The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.'}], 'secondaryOutcomes': [{'measure': 'Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery', 'timeFrame': 'Immediately following Stage I surgery', 'description': 'Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported.'}, {'measure': 'Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points', 'timeFrame': 'Stage 2 Surgery, Months 12, 18 and 24', 'description': 'Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.'}]}, 'conditionsModule': {'conditions': ['Breast Reconstruction']}, 'referencesModule': {'references': [{'pmid': '25502862', 'type': 'DERIVED', 'citation': 'Fine NA, Lehfeldt M, Gross JE, Downey S, Kind GM, Duda G, Kulber D, Horan R, Ippolito J, Jewell M. SERI surgical scaffold, prospective clinical trial of a silk-derived biological scaffold in two-stage breast reconstruction: 1-year data. Plast Reconstr Surg. 2015 Feb;135(2):339-351. doi: 10.1097/PRS.0000000000000987.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo be eligible for enrollment, the subject must:\n\n* Be female, greater or equal to 18 years of age\n* Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a tissue expander, followed by exchange with a sub-pectoral breast implant\n* Have previously had or 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\nThe subject must not:\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 collagen-vascular, connective disease, or bleeding disorders\n* Have a Body Mass Index (BMI) that is greater than or equal to 35\n* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability\n* Have an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer\n* Have smoked within the last 12 months\n* Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit\n* Be pregnant, lactating, or expecting to be within the next 24 months\n* Have concomitant unrelated condition of breast/chest wall/skin\n* Have an abscess or infection at the time of surgery\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': 'NCT01256502', 'briefTitle': 'The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sofregen Medical, Inc.'}, 'orgStudyIdInfo': {'id': 'SURE-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Implanted Participants', 'description': 'Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.', 'interventionNames': ['Device: SERI® Surgical Scaffold']}], 'interventions': [{'name': 'SERI® Surgical Scaffold', 'type': 'DEVICE', 'description': 'Breast reconstruction surgery', 'armGroupLabels': ['Implanted Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan Medical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sofregen Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}