Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-01 @ 5:30 AM
Study NCT ID:
NCT06442605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-06-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time required for fibroid fragmentation and retrieval', 'timeFrame': 'intraoperative', 'description': 'Using a stopwatch, record the time it takes from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag until the complete removal of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag from the abdominal cavity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Leiomyoma, Uterine']}, 'referencesModule': {'references': [{'pmid': '35315012', 'type': 'BACKGROUND', 'citation': 'Wei Y, Zhou X, Ren QZ, Ma Q, Tao X, Shao M, Jia S. A self-developed contained bag for laparoscopic myomectomy morcellation. Ginekol Pol. 2022;93(8):605-613. doi: 10.5603/GP.a2022.0002. Epub 2022 Mar 22.'}, {'pmid': '35187057', 'type': 'BACKGROUND', 'citation': 'Wang W, Liang H, Zhao F, Yu H, Rong C, Feng W, Chen Q, Yang Y, Li Q, Feng D, Dong Y, Xue M, Liang J, Ling B. A Novel Multi-Port Containment System for Laparoscopic Power Morcellation to Prevent Tumoral Spread: A Retrospective Cohort Study. Front Surg. 2022 Feb 3;9:803950. doi: 10.3389/fsurg.2022.803950. eCollection 2022.'}, {'pmid': '26801067', 'type': 'BACKGROUND', 'citation': 'Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'Research Purpose The purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal.\n\nResearch Design This study is a single-center, randomized, single-blind, 1:1 controlled trial.\n\nIntervention Measures Study participants were randomly assigned in a 1:1 ratio into two groups.\n\nExperimental group: Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids.\n\nControl group: Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.\n\nObservation Indicators Primary observation indicator: Time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity).\n\nSecondary observation indicators: Success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with uterine fibroids who meet the surgical indications. Patients aged 18 and above but below 45, who strongly request to preserve the uterus.\n\nPatients planning to undergo laparoscopic myomectomy. Those who understand the purpose, procedures, potential risks of this trial, voluntarily participate in this study, and sign the informed consent form.\n\nExclusion Criteria:\n\nPatients who cannot tolerate laparoscopic surgery due to their overall physical condition.\n\nPatients with multiple fibroids have at least 4 fibroids, with the largest diameter of a single fibroid being equal to or greater than 10cm.\n\nPatients who require surgical procedures other than laparoscopic myomectomy (excluding pelvic adhesion lysis, resection of mesosalpingeal cysts measuring less than 2cm, and superficial intraperitoneal lesions resection/electrocoagulation).\n\nPreoperatively considering the possibility of uterine fibroid malignancy. Patients with preoperative unclear diagnosis, requiring differentiation from ovarian tumors.\n\nPreviously undergone lower abdominal or pelvic intraperitoneal surgery, or patients with severe pelvic or abdominal adhesions.\n\nPresence of untreated infectious sexual diseases, including but not limited to vaginitis, cervical inflammatory diseases, and pelvic inflammatory diseases.\n\nPatients who cannot understand the research protocol, cannot cooperate with the research and follow-up, and any other patients that researchers deem unsuitable for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06442605', 'briefTitle': 'Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy', 'orgStudyIdInfo': {'id': '2024016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids.', 'interventionNames': ['Device: single-channel uterine fibroid morcellation system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.', 'interventionNames': ['Device: Multi-channel specimen retrieval bag + conventional laparoscopic uterine fibroid morcellator']}], 'interventions': [{'name': 'single-channel uterine fibroid morcellation system', 'type': 'DEVICE', 'description': 'Conventional laparoscopic myomectomy is performed with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids during the procedure.', 'armGroupLabels': ['Experimental group']}, {'name': 'Multi-channel specimen retrieval bag + conventional laparoscopic uterine fibroid morcellator', 'type': 'DEVICE', 'description': 'In conventional laparoscopic myomectomy, a multi-channel specimen retrieval bag is used during the procedure, along with a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou First People's Hospita", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yahui Wang', 'role': 'CONTACT', 'email': '362303714@qq.com', 'phone': '+8615158150768'}], 'overallOfficials': [{'name': 'Jinyi Tong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If necessary, other researchers can ask us to share the raw data via email after the results are published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}