Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT04738734
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2021-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014860', 'term': 'Warts'}], 'ancestors': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bknape@pulsebiosciences.com', 'phone': '510-906-4649', 'title': 'William A. Knape, VP Clinical, Regulatory, and Quality Affairs', 'organization': 'Pulse Biosciences, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '150 days', 'eventGroups': [{'id': 'EG000', 'title': 'CellFX Procedure', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 10, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cryosurgical Procedure', 'description': 'Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.\n\nCryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 2, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin Neoplasm', 'notes': 'Presence of non-melanoma skin cancer (SCC) was at the site of the treated lesion along with an Actinic Keratotic lesion treated with Cryotherapy. One participant showed a BCC lesion not related to treatment site.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neoplasm of uncertain behavior of skin', 'notes': 'Biopsy showed wart', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Paraesthesia', 'notes': 'Numbness or altered sensation at the site of treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neuropathy', 'notes': 'Sensory disturbance including numbness or altered sensation and resolved within 2-6 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infection', 'notes': 'Suspect Skin Infection, no culture collected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tinea Versicolor', 'notes': 'Participant has recurrent fungal infections that usually have resolved within 2 months.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain', 'notes': 'Post-procedure pain for one participant that resolved less than 24 hours. Second participant had persistent pain post treatment that resolved within 5 months without intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Warts Resolved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}, {'units': 'wart lesions', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CellFX Procedure', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.'}, {'id': 'OG001', 'title': 'Cryosurgical Procedure', 'description': 'Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.\n\nCryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.7', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '90.2'}, {'value': '73.1', 'groupId': 'OG001', 'lowerLimit': '64.2', 'upperLimit': '81.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months', 'description': 'The primary effectiveness endpoint is the percentage of warts resolved or cleared as assessed "live" by the blinded site investigator at 30 days after the last treatment with CellFX or Cryosurgical Procedure.', 'unitOfMeasure': 'percentage of warts resolved', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'wart lesions', 'denomUnitsSelected': 'wart lesions', 'populationDescription': 'The population consisted of participants with treated warts and evaluated at 30-days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months.'}, {'type': 'PRIMARY', 'title': 'Percentage of Warts Treated With Skin Textural Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}, {'units': 'wart lesions', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CellFX Procedure', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.'}, {'id': 'OG001', 'title': 'Cryosurgical Procedure', 'description': 'Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.\n\nCryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '32.5', 'upperLimit': '50.3'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '5.73', 'upperLimit': '20.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months', 'description': 'The safety endpoint is the percentage of warts with skin textural changes where the wart was originally treated and showed textual changes of the surrounding skin where the wart was treated and included; scabbing, swelling, crusting, blister, or ulceration when assessed by the blinded site investigator.', 'unitOfMeasure': 'percentage of warts', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'wart lesions', 'denomUnitsSelected': 'wart lesions', 'populationDescription': 'The population consisted of participants with treated warts and evaluated for skin textural changes at 30-days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months.'}, {'type': 'PRIMARY', 'title': 'Presence of Pigmentary and Scarring Skin Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}, {'units': 'wart lesions', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CellFX Procedure', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.'}, {'id': 'OG001', 'title': 'Cryosurgical Procedure', 'description': 'Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.\n\nCryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000', 'lowerLimit': '25.5', 'upperLimit': '49.0'}, {'value': '23.7', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '33.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months', 'description': 'The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'wart lesions', 'denomUnitsSelected': 'wart lesions', 'populationDescription': 'The population consisted of participants with treated warts and evaluated at 90-days following the last CellFX or Cryosurgical Procedure up to a maximum of 6 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CellFX Procedure', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.'}, {'id': 'FG001', 'title': 'Cryosurgical Procedure', 'description': 'Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.\n\nCryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Mistake of termination of subject by clinical site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CellFX Procedure', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.'}, {'id': 'BG001', 'title': 'Cryosurgical Procedure', 'description': 'Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.\n\nCryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '78'}, {'value': '46.2', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '80'}, {'value': '45.4', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '133', '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': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', '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': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Warts', 'classes': [{'categories': [{'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Total number of enrolled warts per treatment', 'unitOfMeasure': 'warts'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-16', 'size': 899706, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-20T13:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Each subject will be evaluated by the blinded site investigator conducting assessment of outcomes at 7, 30, 60, and 90-days following CellFX and Cryosurgical treatments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2021-01-31', 'resultsFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2021-01-31', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-16', 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Warts Resolved', 'timeFrame': '30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months', 'description': 'The primary effectiveness endpoint is the percentage of warts resolved or cleared as assessed "live" by the blinded site investigator at 30 days after the last treatment with CellFX or Cryosurgical Procedure.'}, {'measure': 'Percentage of Warts Treated With Skin Textural Changes', 'timeFrame': '30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months', 'description': 'The safety endpoint is the percentage of warts with skin textural changes where the wart was originally treated and showed textual changes of the surrounding skin where the wart was treated and included; scabbing, swelling, crusting, blister, or ulceration when assessed by the blinded site investigator.'}, {'measure': 'Presence of Pigmentary and Scarring Skin Changes', 'timeFrame': '90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months', 'description': 'The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CellFX', 'Nano-Pulse Stimulation', 'NPS', 'Clearance', 'Wart Reduction'], 'conditions': ['Warts', 'Warts Hand', 'Verruca']}, 'descriptionModule': {'briefSummary': 'This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar or periungual area in healthy adult subjects.', 'detailedDescription': 'The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. Macrophotography of all study warts will be captured along with a blinded site Investigator to characterize wart healing, wart clearance and wart reduction. All subjects will be followed at 7, 30, 60, and 90-days following the last CellFX or Cryosurgical Procedure. All wart lesions are eligible for up to a total of 3 treatments over the course of the study. Adverse events will be documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must be at least 21 and not older than 80 years of age\n* Subject has a Fitzpatrick Skin Type I, II, III or IV.\n* Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.\n* Subject must comply with study procedures including all follow-up visits.\n* Subject is willing to have warts treated in a single treatment session and understands that their warts may undergo multiple treatment sessions at subsequent visits.\n* Subject must have a minimum of 2 warts and up to 8 warts to be treated.\n* Subject with a clinical diagnosis of common warts located on hands and fingers or other body areas that are not located on the scalp, nose, within the orbital region of the face, plantar, genital or periungual area.\n* For study purposes, the warts must be no greater than 3 mm in height and must not exceed 10mm x 10mm at their largest dimension.\n* Each wart must appear alone and discrete and not appear in clusters.\n* Each wart must have been present for at least 4 weeks.\n* Subject consents to have photographs taken of the warts.\n* Subject agrees to refrain from using all other wart removal products or treatments (e.g.\n\ntopical medication including over-the-counter medications) during the study period.\n\nExclusion Criteria:\n\n* Subject with more than 8 visible warts in total anywhere on the body.\n* Subject has flat, periungual, subungual, genital, anal, mosaic, plantar or filiform warts.\n* Subject has an implantable electronic medical device.(i.e., pacemaker, implantable cardioverter defibrillator)\n* Subject has an active infection or history of infection in designated test area within 90 days prior to first treatment.\n* Subject is taking antihistamines, including those used for gastric symptoms.\n* Subject is prone to Koebnerization or has any of the following conditions (e.g., psoriasis, vitiligo, lichen planus, or an autoimmune disorder of the skin)\n* Subject is not willing or able to sign the Informed Consent.\n* Subject is known to be immune compromised.\n* Subject has allergies to Lidocaine or Lidocaine-like products.\n* Subject is a member of a vulnerable population including individuals employed by the\n* Sponsor, clinic site, or entity associated with the conduct of the study.\n* Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.\n* Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.\n* Subject was previously treated with CellFX for warts."}, 'identificationModule': {'nctId': 'NCT04738734', 'briefTitle': 'CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulse Biosciences, Inc.'}, 'officialTitle': 'A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Cryosurgery for the Treatment of Cutaneous Non-Genital Common Warts', 'orgStudyIdInfo': {'id': 'NP-WC-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CellFX Procedure', 'description': 'CellFX device using pre-defined energy protocols', 'interventionNames': ['Device: CellFX System Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cryosurgical Procedure', 'description': 'Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.', 'interventionNames': ['Device: Cryosurgery Liquid Nitrogen Sprayer']}], 'interventions': [{'name': 'CellFX System Device', 'type': 'DEVICE', 'description': 'The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.', 'armGroupLabels': ['CellFX Procedure']}, {'name': 'Cryosurgery Liquid Nitrogen Sprayer', 'type': 'DEVICE', 'description': 'Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.', 'armGroupLabels': ['Cryosurgical Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigate MD', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Moy-Fincher-Chipps Dermatology', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '80111', 'city': 'Greenwood Village', 'state': 'Colorado', 'country': 'United States', 'facility': 'AboutSkin Dermatology and DermSurgery', 'geoPoint': {'lat': 39.61721, 'lon': -104.95081}}, {'zip': '34685', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Harbor Dermatology', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oak Dermatology', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Juva Skin & Laser Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology, Laser & Vein Specialists of the Carolinas', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Dermatology & Laser Center of Charleston', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Institute for Clinical Research, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78550', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Institute for Clinical Research, Inc.', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}], 'overallOfficials': [{'name': 'Richard Nuccitelli, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pulse Biosciences, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulse Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}