Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-02-10 @ 6:06 AM
Study NCT ID:
NCT01059357
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2010-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jwaltone@wakehealth.edu', 'phone': '3367169068', 'title': 'Dr. Joshua Waltonen', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System\n\nDa Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 7, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blood loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chipped tooth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System\n\nDa Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of surgery, lasting up to 3 hours. Assessed for up to 6 months', 'description': 'In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System\n\nDa Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System'}], 'classes': [{'categories': [{'measurements': [{'value': '321', 'spread': '136.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of surgery, up to 3 hours', 'description': 'The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Blood Loss and Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System\n\nDa Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Time to Set up and Perform Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System\n\nDa Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'spread': '47.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of surgery, up to 3 hours', 'description': 'This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Correctly Predicted Success of TORS Preoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System\n\nDa Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'preoperative', 'description': 'This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.', 'unitOfMeasure': 'procedures', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System\n\nDa Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '13.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected on all participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System\n\nDa Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System\n\nDa Vinci Robotic Transoral Robotic Surgical System: (TORS) Da Vinci Robotic Transoral Robotic Surgical System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.64', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2010-01-21', 'resultsFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2010-01-28', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-13', 'studyFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.', 'timeFrame': 'At time of surgery, lasting up to 3 hours. Assessed for up to 6 months', 'description': 'In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis'}], 'secondaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': 'At time of surgery, up to 3 hours', 'description': 'The total operative times include the induction of and emergence from anesthesia, the TORS procedure, plus any adjunct procedures (eg, neck dissections) performed during the same operation.'}, {'measure': 'Number of Participants With Blood Loss and Complications', 'timeFrame': '6 months'}, {'measure': 'Average Time to Set up and Perform Procedures', 'timeFrame': 'At time of surgery, up to 3 hours', 'description': 'This outcome is to identify the learning curve for TORS by measuring the efficiency of the surgeon who performs the procedures.'}, {'measure': 'Number of Correctly Predicted Success of TORS Preoperatively', 'timeFrame': 'preoperative', 'description': 'This outcome is to identify the learning curve for TORS by measuring the accuracy of the surgeon who performs the procedures.'}, {'measure': 'QOL', 'timeFrame': '6 months', 'description': 'Quality of life (QOL) of the patients undergoing TORS will be measures. The score range is 0-100 with higher scores denoting better outcome.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.', 'detailedDescription': 'Patients are going to be evaluated in their usual regular clinical follow ups starting with preoperative first visit, 3 weeks, 3 months and 6 months postoperatively with a Quality of Life survey (Head and Neck Cancer Inventory, HNCI-QOLQ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must present with indications for diagnostic or therapeutic approaches for benign and malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)\n* Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation\n\nExclusion Criteria:\n\n* Unexplained fever and/or untreated, active infection\n* Patient pregnancy\n* Previous head and neck surgery precluding transoral/robotic procedures\n* The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches'}, 'identificationModule': {'nctId': 'NCT01059357', 'acronym': 'TORS', 'briefTitle': 'Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System', 'orgStudyIdInfo': {'id': 'IRB00009802'}, 'secondaryIdInfos': [{'id': 'CCCWFU 60209', 'type': 'OTHER', 'domain': 'Wake Forest University Health Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transoral Robotic Surgery (TORS)', 'description': 'Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System', 'interventionNames': ['Device: Da Vinci Robotic Transoral Robotic Surgical System']}], 'interventions': [{'name': 'Da Vinci Robotic Transoral Robotic Surgical System', 'type': 'DEVICE', 'otherNames': ['(TORS) Da Vinci Robotic Transoral Robotic Surgical System'], 'description': '(TORS) Da Vinci Robotic Transoral Robotic Surgical System', 'armGroupLabels': ['Transoral Robotic Surgery (TORS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Joshua D. Waltonen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}