Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 2:46 AM
Study NCT ID:
NCT02444533
Status:
COMPLETED
Last Update Posted:
2017-07-14
First Post:
2015-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EXPAREL® for Pain After Tonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014069', 'term': 'Tonsillitis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Price.Daniel@mayo.edu', 'phone': '507-293-4395', 'title': 'Dr. Daniel Price', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '5 weeks post surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Liposomal Bupivacaine', 'description': 'Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy.\n\nLiposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Treatment', 'description': 'Patient will not be given any medications in the tonsillar fossae after tonsillectomy', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score (Pain Scores on a 0/10 Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy\n\nLiposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Patient will not be given any medications in the tonsillar fossae after tonsillectomy'}], 'classes': [{'title': 'day of surgery', 'categories': [{'measurements': [{'value': '3.07', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.79', 'groupId': 'OG001'}]}]}, {'title': '14 days after surgery', 'categories': [{'measurements': [{'value': '1.76', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between groups for pain on day of surgery. Statistical significance was defined as a p-value less than 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.445', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between groups for pain at 14 days after surgery. Statistical significance was defined as a p-value less than 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'day of surgery, 14 days after surgery', 'description': 'Subjects recorded pain scores four times a day in a daily pain diary using a Visual Analog Scale with markings from 0 to 10. 0 indicated "no pain" and 10 indicated "worst possible pain"', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results include only subjects who were reported as having at least partial outcome data.'}, {'type': 'PRIMARY', 'title': 'Pain Medication Usage (Milligrams Used)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy\n\nLiposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Patient will not be given any medications in the tonsillar fossae after tonsillectomy'}], 'classes': [{'title': 'Ibuprofen (Motrin)', 'categories': [{'measurements': [{'value': '14013', 'spread': '18109', 'groupId': 'OG000'}, {'value': '9753', 'spread': '11509', 'groupId': 'OG001'}]}]}, {'title': 'Acetaminophen (Tylenol)', 'categories': [{'measurements': [{'value': '30615', 'spread': '13196', 'groupId': 'OG000'}, {'value': '31287', 'spread': '13185', 'groupId': 'OG001'}]}]}, {'title': 'Oxycodone (OxyContin)', 'categories': [{'measurements': [{'value': '265', 'spread': '246', 'groupId': 'OG000'}, {'value': '244', 'spread': '159', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.650', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between groups for ibuprofen usage. Statistical significance was defined as a p-value less than 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.970', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between groups for acetaminophen usage. Statistical significance was defined as a p-value less than 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.835', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between groups for oxycodone usage. Statistical significance was defined as a p-value less than 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2 weeks after surgery', 'description': 'Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject on the no treatment arm was excluded for lack of follow up data, therefore 18 (from participant flow) -1 = 17.'}, {'type': 'PRIMARY', 'title': 'Oral Intake (Patient Recorded Oral Intake)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy\n\nLiposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Patient will not be given any medications in the tonsillar fossae after tonsillectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '13715', 'spread': '7551', 'groupId': 'OG000'}, {'value': '12492', 'spread': '4271', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between groups at 7 days. Statistical significance was defined as a p-value less than 0.05.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 week after surgery', 'description': 'Subjects recorded oral intake over one week after surgery', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy\n\nLiposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Patient will not be given any medications in the tonsillar fossae after tonsillectomy'}], 'classes': [{'title': 'Allergic reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Swallowing dysfunction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hospital admission related to the study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Post-tonsillectomy Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine', 'description': 'Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy\n\nLiposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.'}, {'id': 'OG001', 'title': 'No Treatment', 'description': 'Patient will not be given any medications in the tonsillar fossae after tonsillectomy'}], 'classes': [{'title': 'Any form of bleeding', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Required a trip back to the operating room', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'No bleeding', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "In the Liposomal Bupivacaine arm, 15 subjects had data on the primary endpoints, and an additional 2 provided information regarding post-procedure complications, but didn't provide data on other outcomes, therefore the analysis population for the Liposomal Bupivacaine is 17."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liposomal Bupivacaine', 'description': 'Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy\n\nLiposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.'}, {'id': 'FG001', 'title': 'No Treatment', 'description': 'Patient will not be given any medications in the tonsillar fossae after tonsillectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Not able to complete forms', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Only gave post-procedure complications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were recruited at the Mayo Clinic in Rochester, Minnesota.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liposomal Bupivacaine', 'description': 'Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy\n\nLiposomal Bupivacaine: Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.'}, {'id': 'BG001', 'title': 'No Treatment', 'description': 'Patient will not be given any medications in the tonsillar fossae after tonsillectomy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demographics include only subjects who were reported as having at least partial outcome data.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-16', 'studyFirstSubmitDate': '2015-05-08', 'resultsFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-16', 'studyFirstPostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score (Pain Scores on a 0/10 Scale)', 'timeFrame': 'day of surgery, 14 days after surgery', 'description': 'Subjects recorded pain scores four times a day in a daily pain diary using a Visual Analog Scale with markings from 0 to 10. 0 indicated "no pain" and 10 indicated "worst possible pain"'}, {'measure': 'Pain Medication Usage (Milligrams Used)', 'timeFrame': '2 weeks after surgery', 'description': 'Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame'}, {'measure': 'Oral Intake (Patient Recorded Oral Intake)', 'timeFrame': '1 week after surgery', 'description': 'Subjects recorded oral intake over one week after surgery'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)', 'timeFrame': '4 weeks', 'description': 'Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.'}, {'measure': 'Number of Subjects With Post-tonsillectomy Bleeding', 'timeFrame': '4 weeks', 'description': 'The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liposomal Bupivacaine'], 'conditions': ['Tonsillectomy', 'Tonsillitis', 'Post-operative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether liposomal bupivacaine (long acting injectable anesthetic) provides greater post operative pain relief compared to the standard post operative pain regiment for tonsillectomy patients.', 'detailedDescription': 'Subjects will be screened in the clinic when being evaluated for indications for tonsillectomy. Once the decision to proceed with tonsillectomy is made, the patient will be given the information on the study, provided time to review the information and interested patients will be consented.\n\nThere will be two stages in the study. The first will be the operative stage, which includes the injection during the operation. The second stage is the patient participation stage. During this stage, the patient records the amount of oral pain medication usage, oral intake after their procedure, in addition to their pain scores. These scores are recorded and brought back (or mailed in) to the clinic for collection during the follow up visit, approximately 1 month later (patients will keep records for two weeks). The patients will be freed from participation in the study after the one month visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy\n* Willing and able to understand and provide written informed consent\n\nExclusion Criteria:\n\n* Known pregnancy\n* Women who are currently nursing a child\n* History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder\n* Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation\n* Inability to provide informed consent (patients under guardianship)\n* Known hypersensitivity to local anesthetics\n* History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.\n* History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as determined by history or review of the medical record.\n* Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate \\< 60 mL/min/body surface area (BSA) as determined by history or review of the medical record.\n* History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.'}, 'identificationModule': {'nctId': 'NCT02444533', 'briefTitle': 'EXPAREL® for Pain After Tonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Phase IV Randomize, Single-Blind, Trial of Liposomal Bupivacaine (EXPAREL®) for Pain Control in Post-Tonsillectomy Patients', 'orgStudyIdInfo': {'id': '14-007071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal Bupivacaine', 'description': 'Patient will receive liposomal bupivacaine in the tonsillar fossae after tonsillectomy', 'interventionNames': ['Drug: Liposomal Bupivacaine']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'Patient will not be given any medications in the tonsillar fossae after tonsillectomy'}], 'interventions': [{'name': 'Liposomal Bupivacaine', 'type': 'DRUG', 'otherNames': ['Exparel'], 'description': 'Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.', 'armGroupLabels': ['Liposomal Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Daniel L Price, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Daniel L. Price, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}