Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02658851
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2016-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cold Plasma for the Reduction of Lymphoceles Following PLND
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008210', 'term': 'Lymphocele'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kari.larson@apyxmedical.com', 'phone': '8012440058', 'title': 'Kari Larson', 'organization': 'Apyx Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected beginning at the day of surgery and collected to the 8 week follow-up visit (8 weeks, +/- 4 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'J-Plasma', 'description': "Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.\n\nJ-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.", 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Incidence of Lymphocele Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'J-Plasma', 'description': "Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.\n\nJ-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'J-Plasma', 'description': "Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.\n\nJ-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'J-Plasma', 'description': "Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.\n\nJ-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.28', 'spread': '7.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-Op Prostate-Specific Antigen (PSA)', 'classes': [{'categories': [{'measurements': [{'value': '7.97', 'spread': '5.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pre-Operative Biopsy Gleason', 'classes': [{'categories': [{'measurements': [{'value': '7.45', 'spread': '0.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Gleason scores range from 2 to 10, and most prostate cancer will score 6 or higher. A higher score (8 to 10) means the type of cancer has a higher risk of growing and spreading.', 'unitOfMeasure': 'units on a scale (Scale 2 - 10)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-25', 'size': 380120, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-09T12:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2016-01-15', 'resultsFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2016-01-15', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-01', 'studyFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Incidence of Lymphocele Formation', 'timeFrame': '12 weeks', 'description': 'The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['lymphocele', 'pelvic lymph node dissection', 'robotic assisted radical prostatectomy', 'PLND', 'RARP', 'prostatectomy', 'Patel'], 'conditions': ['Lymphoceles Following Pelvic Lymph Node Dissection']}, 'descriptionModule': {'briefSummary': "This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.", 'detailedDescription': "Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy who have met the study inclusion criteria and who have also given informed consent will be enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is present. The occurrence rate of lymphoceles in this trial group will be compared to retrospective data from the principal investigator's practice and other published data to determine if the occurrence rate has been reduced."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary diagnosis of Prostate Cancer (ICD-10:C61)\n2. Prostate Specific Antigen (PSA) level =/\\> 10ng/mL\n3. Gleason score =/\\> 7\n4. Planned Elective Robotic Assisted Radical Prostatectomy with planned pelvic lymph node dissection.\n5. Willing and able to return to clinic for standard of care abdominal ultrasound within 12 weeks post operatively.\n6. Able to provide informed consent\n\nExclusion Criteria:\n\nMust answer no to all:\n\n1. Patient is unwilling or unable to sign or understand informed consent\n2. Patient resides outside of the United States\n3. Performance of Lymph node dissection was aborted.'}, 'identificationModule': {'nctId': 'NCT02658851', 'briefTitle': 'Cold Plasma for the Reduction of Lymphoceles Following PLND', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apyx Medical'}, 'officialTitle': 'Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy', 'orgStudyIdInfo': {'id': '808076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'J-Plasma', 'description': 'Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.', 'interventionNames': ['Device: J-Plasma']}], 'interventions': [{'name': 'J-Plasma', 'type': 'DEVICE', 'otherNames': ['Cold plasma'], 'description': "Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.", 'armGroupLabels': ['J-Plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Global Robotics Institute', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}], 'overallOfficials': [{'name': 'Vipul R Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Hospital Global Robotics Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apyx Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AdventHealth', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}