Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 11:02 AM
Study NCT ID:
NCT05945433
Status:
RECRUITING
Last Update Posted:
2023-07-14
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anovo™ Surgical System - Registry Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '8 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Surgeon Learning Curve (surgery time against number of operations performed, considering frequency of cases and surgery difficulty)', 'timeFrame': 'Procedure', 'description': 'To be reported as a continuous curve (plot per surgeon), and as the mean difference in surgery times between during learning curve and after learning curve stages (stages defined as before the surgeon achieves a steady state surgical time and after the surgeon achieves the steady state)'}, {'measure': 'Surgeon Safety Curve (cumulative UADEs against number of operations performed)', 'timeFrame': 'Procedure'}, {'measure': 'User Skills Development Survey', 'timeFrame': 'Procedure'}], 'primaryOutcomes': [{'measure': 'Conversion rate to open or laparoscopic approach', 'timeFrame': 'Procedure'}, {'measure': 'Rate of Unanticipated Adverse Device Effect', 'timeFrame': '8 Weeks Follow Up'}], 'secondaryOutcomes': [{'measure': 'Surgery time (minutes)', 'timeFrame': 'Procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['GYN Disorders']}, 'descriptionModule': {'briefSummary': 'To collect Real-World Data (RWD) on the ongoing safety and effectiveness of the anovo Surgical system in transvaginal gynecological laparoscopic surgical procedures and to obtain information on the impact of the anovo Skills Development Pathway on user behavior and performance (where performance is measured by the learning curve of the surgeons and procedure outcomes).', 'detailedDescription': 'Specific Aims:\n\n1. To collect RWD from surgeons with varying experience and expertise on their learning curve and time to achieve competency, and as such assess the success of the Skills Development Pathway.\n2. Collect safety information and analyze the causality between type and frequency of adverse events to surgeons\' experience.\n3. Evaluate the effectiveness of the device while minimizing bias by enrolling "all comers", which will represent the general patient population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry. To be eligible to participate in the registry, patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'All patients receiving gynecological surgical procedure with the anovo Surgical System by their surgeon will be offered to participate in the registry.\n\nInclusion Criteria:\n\n* patients must understand and sign the informed consent form, including data privacy authorization, indicating their consent to participate in the registry study.\n* willing to complete post-operative questionnaire\n\nExclusion Criteria:\n\n-none'}, 'identificationModule': {'nctId': 'NCT05945433', 'briefTitle': 'Anovo™ Surgical System - Registry Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Momentis Surgical'}, 'officialTitle': 'Anovo™ Surgical System - Registry Study', 'orgStudyIdInfo': {'id': 'Momentis2023GYNRegistry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing gynecological surgical procedure with the anovo Surgical System', 'interventionNames': ['Device: anovo™ Surgical System']}], 'interventions': [{'name': 'anovo™ Surgical System', 'type': 'DEVICE', 'description': 'The anovo Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Instrument ARMS during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures.', 'armGroupLabels': ['Patients undergoing gynecological surgical procedure with the anovo Surgical System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jenni Freed, BSN', 'role': 'CONTACT', 'email': 'jenni.freed@adventhealth.com', 'phone': '407-303-9989'}, {'name': 'Erica Stockwell, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AdventHealth', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}], 'centralContacts': [{'name': 'Sharon H Branch', 'role': 'CONTACT', 'email': 'sharon.branch@momentissurgical.com', 'phone': '9543033777'}, {'name': 'Matthew McKittrick', 'role': 'CONTACT', 'email': 'matthew.mckittrick@momentissurgical.com', 'phone': '6106745544'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Momentis Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}