Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT07140835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Pedal-Controlled Surgistep Platform to Improve Ergonomics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rapid Entire Body Assessment (REBA) Scale Score', 'timeFrame': 'During the surgery upto 60 minutes', 'description': 'The REBA (Rapid Entire Body Assessment) score, used to assess the risk of musculoskeletal disorders (MSDs) in work tasks, ranges from 1 to 15. A lower REBA score indicates a lower risk, with scores below 4 considered to have minimal risk. Higher scores indicate increased risk, with scores of 8 or more indicating a high risk that requires immediate attention and intervention'}, {'measure': 'Rapid Upper Limb Assessment (RULA) Scale Score', 'timeFrame': 'During the surgery upto 60 minutes', 'description': 'The RULA (Rapid Upper Limb Assessment) scale ranges from 1 to 7, with lower scores indicating lower risk and higher scores indicating higher risk of musculoskeletal disorders.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ergonomics']}, 'descriptionModule': {'briefSummary': 'Primary Aim: Assess improvement in ergonomics and musculoskeletal discomfort with the Surgistep compared to a standard footstool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '36 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Regularly perform neurosurgical procedures (cranial/spine)\n* Willing to use both devices (multiple times each).\n\nExclusion Criteria:\n\n* Severe MSK conditions preventing device usage\n* Inability/refusal to participate in observation or surveys.'}, 'identificationModule': {'nctId': 'NCT07140835', 'briefTitle': 'Evaluation of the Pedal-Controlled Surgistep Platform to Improve Ergonomics', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Prospective Crossover Study Evaluating the Pedal-Controlled Surgistep Platform to Improve Ergonomics in Neurosurgical Operations', 'orgStudyIdInfo': {'id': '80476'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SurgiStep Platform', 'description': 'The surgeon will be performing the surgery by standing over the SurgiStep Platform. The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons will be using this platform for 2 weeks, after which they will be operating on standard foot stool for 2 weeks.', 'interventionNames': ['Device: SurgiStep Platform', 'Device: Standard Foot stool']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard surgical practice', 'description': 'The surgeon will be performing the surgery by standing over the standard of care (foot stool). The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons use standard foot stool for 2 weeks, and switch to SurgiStep platform for 2 weeks.', 'interventionNames': ['Device: SurgiStep Platform', 'Device: Standard Foot stool']}], 'interventions': [{'name': 'SurgiStep Platform', 'type': 'DEVICE', 'description': 'The Surgistep (pedal-controlled, adjustable platform) allows real-time height adjustment during surgery. The surgeons can adjust the height of the platform.', 'armGroupLabels': ['Standard surgical practice', 'SurgiStep Platform']}, {'name': 'Standard Foot stool', 'type': 'DEVICE', 'description': 'Foot stool is considered as the standard of care during surgery.', 'armGroupLabels': ['Standard surgical practice', 'SurgiStep Platform']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Health Care', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Atman Desai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Atman Desai', 'investigatorAffiliation': 'Stanford University'}}}}