Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 11:06 AM
Study NCT ID:
NCT07096856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
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': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery', 'timeFrame': 'From start of surgery to end of procedure', 'description': 'Rate of successful completion of the cholecystectomy surgical procedure without unplanned conversions to open or other minimally invasive surgery'}, {'measure': 'Rate of serious adverse events up to 30 days post procedure.', 'timeFrame': 'From end of surgery through 30 days post-procedure', 'description': 'Rate of serious adverse events up to 30 days post procedure.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cholecystectomy, Robotic']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn how the Versius Surgical System, a robotic surgery device, works for gallbladder removal surgery (cholecystectomy) in adults. The main questions it aims to answer are:\n\nHow often can the surgery be successfully completed using Versius without needing to switch to a different surgical method?\n\nWhat serious complications, if any, occur within 30 days after surgery?\n\nResearchers will collect information from adult patients who have gallbladder surgery using the Versius system in U.S. hospitals. The purpose is to better understand how the device performs and how patients recover after surgery.\n\nParticipants will:\n\nBe adults age 22 or older who are eligible for minimally invasive gallbladder surgery\n\nUndergo robotic-assisted surgery using the Versius Surgical System\n\nAllow the research team to collect data during surgery and up to 30 days after\n\nComplete standard follow-up visits after discharge\n\nPatients with certain medical conditions, such as cancer, high BMI (≥40 kg/m²), or contraindications to anesthesia or robotic surgery, will not be included in the study.\n\nThis study is sponsored by CMR Surgical Ltd., the manufacturer of the Versius system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy 2. Patients providing written informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Patient unwilling to provide informed consent\n2. Patients undergoing surgery or treatment for malignant disease\n3. Patients undergoing a concomitant surgical procedure\n4. Medical contraindication for general anaesthesia or minimally invasive procedure\n5. Contraindication for undergoing surgery with Versius (Bleeding diathesis, Active pregnancy or BMI ≥40 kg/m2)'}, 'identificationModule': {'nctId': 'NCT07096856', 'briefTitle': 'Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System', 'organization': {'class': 'INDUSTRY', 'fullName': 'CMR Surgical Ltd'}, 'officialTitle': 'Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System', 'orgStudyIdInfo': {'id': 'CA-00583'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic-Assisted Cholecystectomy Using the Versius Surgical System', 'interventionNames': ['Device: Robotic assisted cholecystectomy']}], 'interventions': [{'name': 'Robotic assisted cholecystectomy', 'type': 'DEVICE', 'description': 'Robotic assisted cholecystectomy', 'armGroupLabels': ['Robotic-Assisted Cholecystectomy Using the Versius Surgical System']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMR Surgical Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}