Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT05672368
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2023-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065287', 'term': 'Robotic Surgical Procedures'}], 'ancestors': [{'id': 'D025321', 'term': 'Surgery, Computer-Assisted'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D012371', 'term': 'Robotics'}, {'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion of operation to laparotomy', 'timeFrame': 'Within 30 days of operation', 'description': 'The number and frequency will be reported with 95% confidence intervals.'}, {'measure': 'Incidence of major surgical complications', 'timeFrame': 'Within 30 days of operation', 'description': 'Will be assessed by Clavien-Dindo classification as grade 3 or higher. The number and frequency will be reported with 95% confidence intervals.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Disease or Disorder']}, 'descriptionModule': {'briefSummary': 'This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port \\[SP\\]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures.\n\nOUTLINE:\n\nPatients undergo surgery using the da Vinci SP1098 robotic system on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented informed consent of the participant and/or legally authorized representative\n* Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\> 45\n* Contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders\n* Past history of failed attempt of minimally invasive abdominal or pelvic surgery'}, 'identificationModule': {'nctId': 'NCT05672368', 'briefTitle': 'The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures', 'orgStudyIdInfo': {'id': '22446'}, 'secondaryIdInfos': [{'id': 'NCI-2022-10346', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '22446', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}, {'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device feasibility (da Vinci SP1098 robotic system)', 'description': 'Patients undergo surgery using the da Vinci SP1098 robotic system on study.', 'interventionNames': ['Device: Robot-Assisted Surgery']}], 'interventions': [{'name': 'Robot-Assisted Surgery', 'type': 'DEVICE', 'otherNames': ['Navigation and Robotics', 'Robot Assisted', 'Robotic Surgery'], 'description': 'Undergo surgery using the da Vinci SP device', 'armGroupLabels': ['Device feasibility (da Vinci SP1098 robotic system)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mehdi Moslemi-kebria', 'role': 'CONTACT', 'email': 'mkebria@COH.org', 'phone': '909-949-2242'}, {'name': 'Mehdi Moslemi-kebria', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Mehdi Moslemi-Kebria', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}