Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
Study NCT ID:
NCT07289295
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-07-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Versius Gynecology Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': 'Day of surgery', 'description': 'Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery.'}, {'measure': 'Serious Adverse Event rate', 'timeFrame': 'Up to 30 days post procedure', 'description': 'Rate of total serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'Day of surgery', 'description': 'Surgical time from skin incision to skin closure'}, {'measure': 'Estimated blood loss', 'timeFrame': 'Day of surgery', 'description': 'Amount of blood estimated to be lost during surgery (in mL)'}, {'measure': 'Intra-operative complications', 'timeFrame': 'Day of surgery', 'description': 'Complications that occur during surgery'}, {'measure': 'Blood transfusions', 'timeFrame': 'Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days', 'description': 'Need for blood transfusion during or after surgery as well as amount transfused'}, {'measure': 'Unplanned instrument use', 'timeFrame': 'Day of surgery', 'description': 'Whether unplanned use of non-Versius laparoscopic instruments during surgery occurs as well as at what surgical step'}, {'measure': 'Device deficiencies', 'timeFrame': 'Day of surgery', 'description': 'Any device deficiencies of Versius during surgery'}, {'measure': 'Reoperation within 24 hours', 'timeFrame': '24 hours post-surgery', 'description': 'Need for reoperation after initial surgery'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days', 'description': 'Hospital stay in days from day of surgery until discharge'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 30 days post-surgery', 'description': 'Rate of adverse events'}, {'measure': 'Readmission', 'timeFrame': 'Up to 30 days post-surgery', 'description': 'Hospital readmission after post-surgical discharge'}, {'measure': 'Reoperation within 30 days', 'timeFrame': 'Up to 30 days post-surgery', 'description': 'Need for reoperation as a result of interventional surgery itself or the indication for surgery'}, {'measure': 'Mortality rate', 'timeFrame': 'Up to 30 days post-surgery'}, {'measure': 'Vaginal vault healing', 'timeFrame': '42 days post-surgery', 'description': 'Vaginal vault healing as anticipated for patients that had total laparoscopic hysterectomy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Versius', 'robotic surgery', 'hysterectomy', 'salpingo-oophrectomy', 'gynecology'], 'conditions': ['Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to expand the clinical evaluation of the safety and efficacy of Versius in gynaecology procedures of total robotic assisted hysterectomy and/or salpingo-oophorectomy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female, aged 22 years or above, who provided written informed consent to participate in the study.\n2. Patient deemed suitable for minimally invasive total hysterectomy and/or Salpingo-Oophorectomy, for benign condition.\n3. Patient with BMI ≤40.\n\nExclusion Criteria:\n\n1. Patient unwilling to provide informed consent.\n2. Medical contraindication for general anaesthesia or minimally invasive procedure.\n3. Oncological cases, patient undergoing surgery or treatment for malignant disease.\n4. Clinically assessed Uterus size of \\> 14 pregnancy weeks (Estimated as \\> 14-15 cm longitudinal diameter).\n5. Patient participation in an interventional clinical study that could impact primary outcomes results.\n6. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix A).\n7. Uncontrolled hypertension, uncontrolled diabetes mellitus, or kidney failure.'}, 'identificationModule': {'nctId': 'NCT07289295', 'briefTitle': 'Versius Gynecology Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'CMR Surgical Ltd'}, 'officialTitle': 'Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy', 'orgStudyIdInfo': {'id': 'CA-00574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgery with Versius', 'interventionNames': ['Device: Versius Surgical System']}], 'interventions': [{'name': 'Versius Surgical System', 'type': 'DEVICE', 'description': 'Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures', 'armGroupLabels': ['Surgery with Versius']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40-572', 'city': 'Katowice', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Main contact', 'role': 'CONTACT', 'email': 'knowosielski@sum.edu.pl', 'phone': '+32 7894726'}, {'name': 'Krzysztof Nowosielski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}], 'centralContacts': [{'name': 'Mark Slack, MD', 'role': 'CONTACT', 'email': 'mark.slack@cmrsurgical.com', 'phone': '+44 7766 024389'}, {'name': 'Chad Schaber, PhD', 'role': 'CONTACT', 'email': 'chad.schaber@cmrsurgical.com'}], 'overallOfficials': [{'name': 'Krzysztof Nowosielski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMR Surgical Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}