Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-01 @ 6:42 PM
Study NCT ID:
NCT01345903
Status:
WITHDRAWN
Last Update Posted:
2012-11-09
First Post:
2011-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic-Assisted Surgery in Treating Patients With Spine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013120', 'term': 'Spinal Cord Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The protocol needs to be re-designed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2012-11-08', 'studyFirstSubmitDate': '2011-04-28', 'studyFirstSubmitQcDate': '2011-04-29', 'lastUpdatePostDateStruct': {'date': '2012-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication rates with 95% confidence bounds of +/- 31% or smaller', 'timeFrame': 'For 100 days post-surgery'}, {'measure': 'Estimated blood loss', 'timeFrame': 'For 100 days post-surgery'}, {'measure': 'Operation duration', 'timeFrame': 'At the completion of surgery'}, {'measure': 'Complication rate', 'timeFrame': 'For 100 days post-surgery'}, {'measure': 'Demographic and clinical data such as stage, grade and histology', 'timeFrame': 'At baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adult Spinal Cord Neoplasm', 'Spinal Bone Metastases', 'Spinal Cord Metastases']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To perform a small pilot study that will demonstrate the feasibility of neurosurgical spinal procedures using the da Vinci surgical robot.\n\nSECONDARY OBJECTIVES:\n\nI. To compare complication rates, operative time and estimated blood loss with historical controls.\n\nII. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and hardware failure.\n\nII. Routine imaging of the spinal segment.\n\nOUTLINE:\n\nPatients undergo robotic-assisted surgery using the da Vinci robot.\n\nAfter completion of study treatment, patients are followed up for 100 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has primary or secondary spine tumor based on computed tomography (CT) or magnetic resonance imaging (MRI)\n* Karnofsky performance status (PS) of \\>= 80 or Eastern Cooperative Oncology Group (ECOG) PS 0-1\n* Expected survival greater than 3 months\n* Patient must be able to understand and sign a study-specific informed consent form\n\nExclusion Criteria:\n\n* Previous surgery at that specific segment\n* Radiation at that specific spinal segment within the last 2 months\n* Karnofsky PS \\< 80 or ECOG PS \\> 1\n* Pregnancy (due to risk of anesthesia)\n* The presence of medical conditions which contraindicate general anesthesia\n* Unexplained fever or untreated, active infection\n* Inability to obtain exposure to allow performance of the planned spine surgical procedure\n* History of psychiatric condition or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance'}, 'identificationModule': {'nctId': 'NCT01345903', 'briefTitle': 'Robotic-Assisted Surgery in Treating Patients With Spine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors', 'orgStudyIdInfo': {'id': '09202'}, 'secondaryIdInfos': [{'id': 'NCI-2011-00691', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (surgery)', 'description': 'Patients undergo robotic-assisted surgery using the da Vinci robot', 'interventionNames': ['Procedure: therapeutic conventional surgery']}], 'interventions': [{'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Undergo robotic-assisted surgery', 'armGroupLabels': ['Treatment (surgery)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mike Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}