Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-02 @ 12:51 AM
Study NCT ID:
NCT02488135
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2015-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Management of Persistent Epistaxis Using Floseal Hemostatic Matrix
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sipmurray@gmail.com', 'phone': '587-891-6240', 'title': 'Scott Murray', 'organization': 'University of Alberta'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Lack of blinding to either patient or practitioner. 30 day follow-up limit on outcomes and adverse events'}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Floseal Hemostatic Matrix', 'description': 'Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot.\n\nFloseal Hemostatic Matrix: Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Traditional Nasal Packing', 'description': 'Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis.\n\nTraditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Initial Hemostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Floseal Hemostatic Matrix', 'description': 'Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot.\n\nFloseal Hemostatic Matrix: Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.'}, {'id': 'OG001', 'title': 'Traditional Nasal Packing', 'description': 'Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis.\n\nTraditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'An a priori sample size was calculated using a non-inferiority limit (d) set at 25%, significance level (α) of 5% and power of 80%. We assumed that success in each group would be 93% based on the literature examining anterior nasal packing in ideal conditions and considering our selection criteria in the Floseal® (Baxter, USA) population. Attrition was assumed to be 0% due to the short duration of treatment. This yielded 26 participants with 13 patients in each study arm.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 hours', 'description': 'Residents administering the treatments will empirically observe primary hemostasis. Any active bleeding requiring further intervention within 4 hours of treatment will be defined as failure of initial hemostasis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Pain Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Floseal Hemostatic Matrix', 'description': 'Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot.\n\nFloseal Hemostatic Matrix: Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.'}, {'id': 'OG001', 'title': 'Traditional Nasal Packing', 'description': 'Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis.\n\nTraditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.'}], 'classes': [{'title': 'Pain Score During Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.42', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '7.77', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '10'}]}]}, {'title': 'Pain Score During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '4.46', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Pain Score During Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '3.85', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'analyses': [{'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between groups for pain during placement.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between groups for pain during treatment.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between scores for pain during removal.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Patients will be contacted 48 hours following treatment with either Floseal or traditional nasal packing and be asked to rate their pain on a 10-point "Visual Analog Pain Scale". They will rate their pain for: 1) the placement of the treatment, 2) the duration of the treatment AND 3) the removal of the treatment.\n\nMinimum: 0 (less pain) Maximum: 10 (more pain)\n\nHigher scores indicate more pain and lower scores indicate less pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that failed initial hemostasis were traditionally packed and therefore were not able to rate either treatment or removal of the product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Floseal Hemostatic Matrix', 'description': 'Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot.\n\nFloseal Hemostatic Matrix: Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.'}, {'id': 'FG001', 'title': 'Traditional Nasal Packing', 'description': 'Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis.\n\nTraditional Nasal Packing: Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Floseal Hemostatic Matrix', 'description': 'Floseal Hemostatic Matrix provided as treatment.'}, {'id': 'BG001', 'title': 'Traditional Nasal Packing', 'description': 'Traditional nasal packing provided as treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.95', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '95'}, {'value': '55.08', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '86'}, {'value': '57.02', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '95'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Charlson Comorbidity Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.31', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2.31', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '2.31', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '7'}]}]}], 'paramType': 'MEAN', 'description': 'The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes.\n\nEach comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient.\n\nA score of zero indicates that no comorbidities were found. The higher the score (max: 24) , the more likely the predicted outcome will result in mortality or higher resource use.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'Aspirin Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-08', 'size': 1137528, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-08-22T14:25', 'hasProtocol': True}, {'date': '2018-10-12', 'size': 59882, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-12T16:36', 'hasProtocol': False}, {'date': '2015-08-27', 'size': 491596, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-08-22T14:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-25', 'studyFirstSubmitDate': '2015-06-26', 'resultsFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-25', 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Initial Hemostasis', 'timeFrame': '4 hours', 'description': 'Residents administering the treatments will empirically observe primary hemostasis. Any active bleeding requiring further intervention within 4 hours of treatment will be defined as failure of initial hemostasis.'}], 'secondaryOutcomes': [{'measure': 'Patient Pain Level', 'timeFrame': '48 hours', 'description': 'Patients will be contacted 48 hours following treatment with either Floseal or traditional nasal packing and be asked to rate their pain on a 10-point "Visual Analog Pain Scale". They will rate their pain for: 1) the placement of the treatment, 2) the duration of the treatment AND 3) the removal of the treatment.\n\nMinimum: 0 (less pain) Maximum: 10 (more pain)\n\nHigher scores indicate more pain and lower scores indicate less pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Floseal® (Baxter, USA)', 'epistaxis', 'nasal packing', 'persistent'], 'conditions': ['Epistaxis']}, 'referencesModule': {'references': [{'pmid': '29310703', 'type': 'DERIVED', 'citation': 'Murray S, Mendez A, Hopkins A, El-Hakim H, Jeffery CC, Cote DWJ. Management of Persistent Epistaxis Using Floseal Hemostatic Matrix vs. traditional nasal packing: a prospective randomized control trial. J Otolaryngol Head Neck Surg. 2018 Jan 8;47(1):3. doi: 10.1186/s40463-017-0248-5.'}]}, 'descriptionModule': {'briefSummary': 'Nosebleeds that persist even after adequate traditional nasal packing may require aggressive treatment strategies to stop bleeding. Currently these strategies include a surgical approach to cut off blood supply to the vessel that is bleeding. FloSeal Hemostatic matrix is a gel like medical therapy that is inserted into the nose and is engineered to stop bleeding in severe cases, possibly avoiding the need for surgery. In this study the investigators will randomize patients to either receive FloSeal Hemostatix matrix or traditional nasal packing as a treatment for severe nosebleeds. The main outcome will be whether the investigators are able to stop bleeding with FloSeal or traditional packing alone and whether additional measures are necessary to stop the bleeding. The investigators will also perform a patient comfort survey and cost analysis. Even if FloSeal has equal effectiveness in treating nosebleeds as traditional packing, if it is much more comfortable for patients then it may be the favourable treatment.', 'detailedDescription': 'Background: Epistaxis is the most common emergent consultation to otolaryngology-head \\& neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy¬ and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis.\n\nMethods: A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 hours post-treatment, and 2) self-reported patient comfort at 48 hours post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients age 18+ presenting with epistaxis that requires an ENT consult that had a first attempt at treatment by an emergency physician.\n\nExclusion Criteria:\n\n* Patients will be excluded based on the presence of a hypo-coagulable state. Including patients actively taking anti-coagulant medications or other patients with either acquired or hereditary bleeding disorders.'}, 'identificationModule': {'nctId': 'NCT02488135', 'briefTitle': 'Management of Persistent Epistaxis Using Floseal Hemostatic Matrix', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Management of Persistent Anterior Epistaxis Using Floseal Hemostatic Matrix vs. Traditional Nasal Packing: A Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '6601059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Floseal Hemostatic Matrix', 'description': 'Patients will receive Floseal Hemostatic Matrix topically at the location of active bleeding. Floseal is a gel-like fibrin glue that is applied using a syringe and forms a hemostatic clot.', 'interventionNames': ['Device: Floseal Hemostatic Matrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Nasal Packing', 'description': 'Patients will receive traditional nasal packing to try and abort bleeding. This includes either vaseline gauze or nasal merocels being inserted into the anterior nasal cavity using forceps. These expand upon contact with blood or liquid therefore creating a compression type hemostasis.', 'interventionNames': ['Procedure: Traditional Nasal Packing']}], 'interventions': [{'name': 'Floseal Hemostatic Matrix', 'type': 'DEVICE', 'description': 'Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.', 'armGroupLabels': ['Floseal Hemostatic Matrix']}, {'name': 'Traditional Nasal Packing', 'type': 'PROCEDURE', 'description': 'Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.', 'armGroupLabels': ['Traditional Nasal Packing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'David Cote, MD, FRCS(C)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alberta Health services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}