Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 9:39 AM
Study NCT ID:
NCT04554394
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2020-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CellFX System for the Treatment of Cutaneous Non-Genital Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-28', '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': 'bill.knape@pulsebiosciences.com', 'phone': '(919) 757-2033', 'title': 'William A. Knape', 'organization': 'Pulse Biosciences, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 months after initial CellFX Treatment', 'eventGroups': [{'id': 'EG000', 'title': 'CellFX Treated Wart Lesion', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX 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': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 8, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Peripheral Sensory Neuropathy', 'notes': 'Transient Numbness at the Target Site resolving without medical intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Pain at Treatment Site treated with Motrin.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': 'Suspect infection. Neosporin used in one subject and antibiotic used in second subject with both events resolving within 2 weeks. No cultures performed for both subjects. Third subject had a negative culture and event resolved within 5 days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness and swelling', 'notes': 'Numbness and swelling reported at the index finger of right hand and took Motrin as needed with resolution of event by 1-month.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Verrucae Cleared', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}, {'units': 'common verrucae', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Warts Treated With CellFX (Common, Flat, and Plantar)', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60-days post-last CellFX treatment', 'description': 'Percentage of Verrucae with Clearance (91-100% reduction)', 'unitOfMeasure': 'percentage of verrucae clearance', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'common verrucae', 'denomUnitsSelected': 'common verrucae', 'populationDescription': 'Percent of verrucae clearance observed at 60-days post-last treatment. Reduction in verrucae size and/or clearance not assessed in the "Non-treated Control" Arm/Group or similar.'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}, {'units': 'total treated warts', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CellFX Treated Verrucae', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60-days post-last CellFX treatment', 'description': 'Satisfaction with reduction in verrucae size or clearance of verrucae measured using the following scale; 5 (Satisfied), 4 (Mostly Satisfied), 3 (Partially Satisfied), 2 (Dissatisfied), 1 (Highly Dissatisfied)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'total treated warts', 'denomUnitsSelected': 'total treated warts', 'populationDescription': 'All Treated Verrucae observed at 60-days post-last CellFX treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CellFX Treated Warts', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX 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': 'Non-Treated Controls', 'description': 'Non-treated wart arm, one study wart per enrolled subject.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '195', 'numSubjects': '62'}, {'comment': 'A total of 62 participants were enrolled and 1 randomized control wart per participant was enrolled in the control arm', 'groupId': 'FG001', 'numUnits': '62', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '136', 'numSubjects': '53'}, {'groupId': 'FG001', 'numUnits': '53', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '59', 'numSubjects': '9'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Clinical Site Closed due to COVID-19 Restrictions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'lesions', 'recruitmentDetails': 'A total of 62 study subjects were enrolled. A total of 257 warts were studied, including 195 warts assigned to treatment and 62 assigned to control arm.', 'preAssignmentDetails': '62 subjects were enrolled. One wart per subject was randomized and pre-assigned as the control.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CellFX Treated Verrucae', 'description': 'CellFX device using pre-defined energy protocols\n\nCellFX 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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '15.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The Fitzpatrick skin phototypes (FSP) were developed in Boston in 1975 for use with phototherapy. The scale's original purpose was to help determine a patient's risk of burning or tanning when exposed to UV light. The current scale classifies skin from types I to VI. Type I refers to skin that always burns, while type VI refers to skin that never burns. In general, a lower FSP means a person's skin burns more easily than it tans. A higher FSP means that a person's skin does not burn easily.", 'unitOfMeasure': 'Participants'}, {'title': 'Verrucae Disposition', 'classes': [{'title': 'Treated', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}]}]}, {'title': 'Control', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}, {'title': 'Not treated', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'warts'}, {'title': 'Wart Subtype', 'classes': [{'title': 'Common', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}]}]}, {'title': 'Plantar', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}, {'title': 'Flat', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Subtype of wart treated in the study', 'unitOfMeasure': 'warts'}, {'title': 'Anatomic Location', 'classes': [{'title': 'Hand', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}]}]}, {'title': 'Foot', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}, {'title': 'Leg', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Knee', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Ankle', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Arm', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Elbow', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Wrist', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Torso', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Location of wart lesion', 'unitOfMeasure': 'warts'}, {'title': 'History of Prior Verrucae Treatment', 'classes': [{'title': 'Cryotherapy', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}, {'title': 'Over the Counter Medical Treatment', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': 'Laser Treatment', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Over the Counter and Laser Treatment', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Electrocautery', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Cantharone and Cryotherapy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Investigational Product', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Aldara and Cryotherapy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Laser Treatment and Cryotherapy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Yeast Injection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'warts'}], 'populationDescription': 'Subjects diagnosed with cutaneous warts, including common, flat and plantar subgroups'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-06-04', 'size': 539932, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-30T22:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2020-08-29', 'resultsFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2020-09-12', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-30', 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Verrucae Cleared', 'timeFrame': '60-days post-last CellFX treatment', 'description': 'Percentage of Verrucae with Clearance (91-100% reduction)'}], 'secondaryOutcomes': [{'measure': 'Subject Satisfaction', 'timeFrame': '60-days post-last CellFX treatment', 'description': 'Satisfaction with reduction in verrucae size or clearance of verrucae measured using the following scale; 5 (Satisfied), 4 (Mostly Satisfied), 3 (Partially Satisfied), 2 (Dissatisfied), 1 (Highly Dissatisfied)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CellFX', 'Nano-Pulse Stimulation', 'NPS', 'Clearance'], 'conditions': ['Warts', 'Warts Hand', 'Verruca']}, 'descriptionModule': {'briefSummary': 'This prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on all areas of the body, excluding the face.', '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. One of the warts for each subject will be untreated and will serve as the subject's internal control. Macrophotography of all study warts will be captured along with Investigator assessments using the Wart Measurement Scale (WMS) and lesion measurements for wart reduction. All subjects will be followed at 7, 30, 60, 90 and 120-days post-initial CellFX treatment. All wart lesions are eligible for re-treatment up to 3 times over the course of the study. Adverse events will be documented."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must be at least 21 and not older than 80 years of age\n* Subjects must be able to read and speak English or Spanish\n* Subjects must sign a written informed consent to participate in the study, prior to any study related procedures\n* Subject must have a minimum of two cutaneous non-genital warts, each not exceeding 10 x 10mm\n* Subject is willing to undergo all study-mandated procedures\n* Subject agrees to refrain from using all other wart removal products or treatments (topical medication including over-the-counter medications) during the study period\n\nExclusion Criteria:\n\n* Subject has an implantable electronic medical device. (pacemaker, implantable cardioverter defibrillator, etc.)\n* Subject has cochlear implants\n* Subject has an active systemic infection or history of an infection in the designated treatment area within 90 days of enrollment\n* Subject has a history of and/or current tinnitus\n* Subject is known to be immune-compromised\n* Subject is taking a blood thinning medication (Antiplatelet, Anticoagulation, Factor Xa Inhibitor, etc.)\n* Subject has Type 1 Diabetes and is insulin dependent\n* Subject has a known allergy to Lidocaine or Lidocaine-like products\n* Subject is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study\n* Subject has a comorbidity or condition which may reduce compliance with this protocol, including follow-up visits\n* Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device)'}, 'identificationModule': {'nctId': 'NCT04554394', 'briefTitle': 'CellFX System for the Treatment of Cutaneous Non-Genital Warts', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pulse Biosciences, Inc.'}, 'officialTitle': 'A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts', 'orgStudyIdInfo': {'id': 'NP-WP-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CellFX Treated Wart', 'description': 'Treated wart with CellFX device intervention', 'interventionNames': ['Device: CellFX Device']}, {'type': 'NO_INTERVENTION', 'label': 'Non-treated Wart', 'description': 'Control wart for each enrolled subject without intervention'}], 'interventions': [{'name': 'CellFX 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 Treated Wart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigate MD, LLC', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92130', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic Carmel Valley', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Skin Search of Rochester, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology, Laser & Vein Specialists of the Carolinas, PLLC', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'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'}}}}