Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT00713661
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2008-07-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C518955', 'term': 'TachoSil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@nycomed.com', 'phone': '+45 4677 1111', 'title': 'Clinical Trial Operations', 'organization': 'Nycomed'}, 'certainAgreement': {'otherDetails': "After publication of the results or 24 months after Clinical Trial Report has been finalised, whichever comes first, Nycomed acknowledge the Investigator's rights to publish results from this trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be submitted to Nycomed prior to submission for publication/presentation for review. Review comments will be given within a month from receipt of the manuscript.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The safety population consists of all 25 subjects that received trial treatment.\n\nSAE/AE assessment by neutral questioning "Have you experienced any health problems since the last contact?" by the investigator at each contact (visit or phone).', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Open Surgery Lower', 'otherNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Group 2: Open Surgery Middle/Upper', 'otherNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Group 3: Laparoscopic Surgery Lower', 'otherNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Group 4: Laparoscopic Surgery Middle/Upper', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small bowel obstruction caused by adhesions requiring small bowel resection done open', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anastomotic leakage', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Minor anastomotic leakage', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomaprolaps', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aspiration pneumonia', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pelvic haematoma', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Presacral haematoma', 'notes': 'SAE was reported as not related to TachoSil®.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Open Surgery Lower'}, {'id': 'OG001', 'title': 'Group 2: Open Surgery Middle/Upper'}, {'id': 'OG002', 'title': 'Group 3: Laparoscopic Surgery Lower'}, {'id': 'OG003', 'title': 'Group 4: Laparoscopic Surgery Middle/Upper'}], 'classes': [{'title': 'Video not available', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Feasible', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Not feasible', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery', 'description': 'Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT + Safety Analysis Set.\n\nAll applications recorded as "not feasible" by external assessor was because he was not able to see it all the way around the anastomosis. The implication is that the primary endpoint was not really reporting the true feasibility, as it was hindered due to technical/practical problems recording the whole anastomosis.'}, {'type': 'SECONDARY', 'title': 'The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Open Surgery Lower'}, {'id': 'OG001', 'title': 'Group 2: Open Surgery Middle/Upper'}, {'id': 'OG002', 'title': 'Group 3: Laparoscopic Surgery Lower'}, {'id': 'OG003', 'title': 'Group 4: Laparoscopic Surgery Middle/Upper'}], 'classes': [{'title': 'Feasible', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Not feasible', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery', 'description': 'Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are presented for the 25 subjects treated with TachoSil®. They constitute the intention-to-treat (ITT) and the safety analysis set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Open Surgery Lower', 'description': 'Open colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.'}, {'id': 'FG001', 'title': 'Group 2: Open Surgery Middle/Upper', 'description': 'Open colorectal resection. The anastomotic line in the middle/upper segment 5-12 cm from the anal verge.'}, {'id': 'FG002', 'title': 'Group 3: Laparoscopic Surgery Lower', 'description': 'Laparoscopic colorectal resection. The anastomotic line in the low segment approximately 0-5 cm from the anal verge.'}, {'id': 'FG003', 'title': 'Group 4: Laparoscopic Surgery Middle/Upper', 'description': 'Laparasocopic colorectal resection. The anastomotic line in the mid/upper segment 5-12 cm from the anal verge.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Subjects were divided into\n\n* Surgery method: open or laparoscopic\n* Location of the anastomosis:\n\n * anastomotic line in the low segment (approx. 0-5 cm from the anal verge)\n * anastomotic line in the mid or upper segment (approx. 5-12 cm from the anal verge)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Open Surgery Lower'}, {'id': 'BG001', 'title': 'Group 2: Open Surgery Middle/Upper'}, {'id': 'BG002', 'title': 'Group 3: Laparoscopic Surgery Lower'}, {'id': 'BG003', 'title': 'Group 4: Laparoscopic Surgery Middle/Upper'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '64.6', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '68.5', 'spread': '9.9', 'groupId': 'BG002'}, {'value': '65.2', 'spread': '12.0', 'groupId': 'BG003'}, {'value': '65.1', 'spread': '10.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2008-07-07', 'resultsFirstSubmitDate': '2011-12-20', 'studyFirstSubmitQcDate': '2008-07-10', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-01', 'studyFirstPostDateStruct': {'date': '2008-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor', 'timeFrame': 'Day of surgery', 'description': 'Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.'}], 'secondaryOutcomes': [{'measure': 'The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.', 'timeFrame': 'Day of surgery', 'description': 'Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Colorectal Anastomosis', 'Colorectal Resection', 'Tachosil'], 'conditions': ['Colorectal Anastomosis']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate if the application of TachoSil® on a colorectal anastomosis is feasible and safe.\n\nThe secondary objective is to establish and describe optimal application methods to be used for educational purposes in future trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - at screening:\n\n* Has the patient given informed consent according to local requirements before any trial-related activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject.\n* Is the subject 18 years of age or above?\n* Is the subject scheduled for elective resection of the rectum?\n* Is a colorectal anastomosis below the peritoneal reflexion planned?\n\nFor females of childbearing potential:\n\n* Does the patient use an acceptable contraceptive method (contraceptive pills, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches or intrauterine device (IUD))?\n* Is the blood or urine pregnancy test negative?\n\nExclusion Criteria -at screening:\n\n* Is the subject scheduled for emergency resection of the rectum?\n* Does the subject suffer from inflammatory bowel diseases?\n* Does the subject have a history of hypersensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?\n* Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?\n* Does the subject participate or plan to participate in another clinical trial during the trial period?\n\nFor females of childbearing potential:\n\n• Is the subject pregnant or breast feeding?\n\nExclusion - peroperative\n\n* Was an anastomosis performed differently from what was defined in the inclusion criteria?\n* Did the subject receive any fibrin sealant/glue, excluding TachoSil® , during surgery?'}, 'identificationModule': {'nctId': 'NCT00713661', 'briefTitle': 'Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nycomed'}, 'officialTitle': 'Non-randomised, Open, Multi-center Trial Evaluating Feasibility and Safety of TachoSil® Application on a Colorectal Anastomosis.', 'orgStudyIdInfo': {'id': 'TC-029-IM'}, 'secondaryIdInfos': [{'id': '2007-007254-62', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TachoSil®', 'interventionNames': ['Drug: TachoSil®']}], 'interventions': [{'name': 'TachoSil®', 'type': 'DRUG', 'description': "Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin.\n\nSurgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy.", 'armGroupLabels': ['TachoSil®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigational site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Investigational site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Dartford', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Investigational site', 'geoPoint': {'lat': 51.44657, 'lon': 0.21423}}], 'overallOfficials': [{'name': 'Nycomed Clinical Trial Operations', 'role': 'STUDY_CHAIR', 'affiliation': 'Headquarters'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nycomed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}