Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT04301934
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2020-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}, {'id': 'D004958', 'term': 'Estradiol'}], 'ancestors': [{'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Yi.Johnny@mayo.edu', 'phone': '480-342-0612', 'title': 'Johnny Yi, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from baseline to end of study, approximately 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Vaginal Estrogen Therapy Group', 'description': 'Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly\n\nConjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women\n\nEstradiol: Current standard treatment for recurrent UTIs in postmenopausal women', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Laser Therapy Group', 'description': 'Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart.\n\nMona Lisa Touch: Fractional CO2 LASER', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Urospepsis with positive urine and blood cultures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of Urinary Tract Infections (UTI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaginal Estrogen Therapy Group', 'description': 'Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly\n\nConjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women\n\nEstradiol: Current standard treatment for recurrent UTIs in postmenopausal women'}, {'id': 'OG001', 'title': 'Laser Therapy Group', 'description': 'Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart.\n\nMona Lisa Touch: Fractional CO2 LASER'}], 'classes': [{'title': 'No UTI', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': '1 + UTI', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Farrington-Manning', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The prevalence of UTI for the LASER group and vaginal estrogen group was calculated. Non-inferiority test using Farrington-Manning method was applied to test the risk difference against the pre-specified non-inferiority margin (20%).'}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'Prevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaginal Estrogen Therapy Group', 'description': 'Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly\n\nConjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women\n\nEstradiol: Current standard treatment for recurrent Urinary Tract Infections (UTI) in postmenopausal women'}, {'id': 'FG001', 'title': 'Laser Therapy Group', 'description': 'Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart.\n\nMona Lisa Touch: Fractional CO2 LASER'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vaginal Estrogen Therapy Group', 'description': 'Women randomized to vaginal estrogen therapy were offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly\n\nConjugated estrogen: Current standard treatment for recurrent UTIs in postmenopausal women\n\nEstradiol: Current standard treatment for recurrent UTIs in postmenopausal women'}, {'id': 'BG001', 'title': 'Laser Therapy Group', 'description': 'Women randomized to the laser therapy group underwent 3 treatments, 6 weeks apart.\n\nMona Lisa Touch: Fractional CO2 LASER'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'spread': '6.41', 'groupId': 'BG000'}, {'value': '69.1', 'spread': '9.47', 'groupId': 'BG001'}, {'value': '68.0', 'spread': '7.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-01', 'size': 261452, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-21T12:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-01', 'studyFirstSubmitDate': '2020-03-06', 'resultsFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-01', 'studyFirstPostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Urinary Tract Infections (UTI)', 'timeFrame': '4 months', 'description': 'Prevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Urinary Tract Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial to determine clinical and microbiome difference between fractional CO2 Laser and vaginal estrogen in treating patients with recurrent urinary tract infection (UTI).', 'detailedDescription': 'Recurrent urinary tract infection (rUTI) is common in postmenopausal women and can lead to significant bothersome symptoms. This clinical scenario is a difficult and common clinical problem seen by the urologist and urogynecologist with limited options for treatment. Overuse of antibiotics has led to significant resistant microorganisms and can have adverse side effects such as C. Dificile colitis. Current treatments include topical vaginal estrogen and prophylactic antibiotics. Other supplements such as cranberry pills, methenamine and D-mannose have varying levels of evidence and efficacy.\n\nFractional CO2 LASER vaginal therapy has recently been studied for the treatment of GSM. LASER therapy is currently commercially available and has FDA clearance for use in gynecology. Current evidence shows that with treatment, histologic changes of the vaginal epithelium have shown regeneration to a premenopausal state, along with subjective improvement in GSM symptoms and sexual function. Recent literature has shown improvements in thickening of vaginal epithelium, decreased vaginal pH and improvement in the vaginal microbiome. Based on this, the investigators propose fractional CO2 laser may have a positive impact on women with rUTI.\n\n1. The investigators therefore hypothesize that fractional CO2 LASER vaginal therapy is non-inferior to topical vaginal estrogen therapy for the treatment of rUTI.\n\n a. Primary Outcome: Improvement in recurrence of culture positive UTI\n2. The investigators also hypothesize that LASER therapy will improve the urinary and vaginal microbiome, decreasing the uropathogenic presence and increasing Lactobacillus.\n\n 1. Measurement 1: The number of UTI with UPEC isolated from patients\n 2. Measurement 2: The pH of the vagina as a proxy for presence of Lactobacillus sp.\n 3. Measurement 3: Categorize vaginal and urinary microbial communities\n3. The investigators hypothesize that LASER therapy will improve symptoms of GSM and be associated with regenerative change in vaginal histology.\n\n 1. Measurement 1: MESA and DIVA surveys of symptoms\n 2. Measurement 2: Observations of vaginal biopsy between.\n\nMenopausal women will be recruited if subjects have recurrent UTI defined as 3 culture positive UTIs in 1 year or 2 culture positive UTIs in 6 months. Subjects will be randomized to standard of care with topical vaginal estrogen or 3 treatments of fractional CO2 LASER of the vagina. Samples will be collected to show microbiome and histologic changes with treatment.\n\nSamples include:\n\nVaginal culture Urine culture vaginal biopsy (optional).\n\nValidated questionnaires and clinical recurrence of UTI will also be gathered over 6 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient \\>18 years old\n* Postmenopausal status, documented by prior bilateral salpingo-oophorectomy, or absence of menses \\>12 months\n* Recurrent urinary tract infections as defined by 3 culture positive urine cultures in the last 12 months, or 2 positive urine cultures in the last 6 months.(Positive urine cultures defined by \\>100K colony forming units of 1 or 2 bacterial species on clean catch sample, or \\>1000 colony forming units of 1 or 2 bacterial species on sample via straight catheterization).\n* Patients on vaginal estrogen must undergo a 1 month washout period prior to initiation of the trial.\n\nExclusion Criteria:\n\n* Hematuria without appropriate workup\n* Pelvic organ prolapse at or beyond the hymen\n* Clinically relevant urinary retention\n* Pelvic reconstructive surgery within 6 months\n* Prior synthetic mesh procedure for pelvic organ prolapse or urinary incontinence\n* Clinically relevant nephrolithiasis\n* History of breast cancer\n* Contraindication to topical estrogen therapy\n* Anticoagulation therapy\n* Prior pelvic or vaginal radiation therapy\n* Prior gynecologic malignancy\n* Undiagnosed genital bleeding'}, 'identificationModule': {'nctId': 'NCT04301934', 'briefTitle': 'Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection', 'orgStudyIdInfo': {'id': '18-002297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vaginal Estrogen Therapy Group', 'description': 'Women randomized to vaginal estrogen therapy will be offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly', 'interventionNames': ['Drug: Conjugated estrogen', 'Drug: Estradiol']}, {'type': 'EXPERIMENTAL', 'label': 'Laser Therapy Group', 'description': 'Women randomized to the laser therapy group will undergo 3 treatments, 6 weeks apart.', 'interventionNames': ['Device: Mona Lisa Touch']}], 'interventions': [{'name': 'Mona Lisa Touch', 'type': 'DEVICE', 'description': 'Fractional CO2 LASER', 'armGroupLabels': ['Laser Therapy Group']}, {'name': 'Conjugated estrogen', 'type': 'DRUG', 'otherNames': ['Premarin'], 'description': 'Current standard treatment for recurrent UTIs in postmenopausal women', 'armGroupLabels': ['Vaginal Estrogen Therapy Group']}, {'name': 'Estradiol', 'type': 'DRUG', 'otherNames': ['Estrace'], 'description': 'Current standard treatment for recurrent UTIs in postmenopausal women', 'armGroupLabels': ['Vaginal Estrogen Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Johnny Yi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Johnny Yi', 'investigatorAffiliation': 'Mayo Clinic'}}}}