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Recruiting
NCT05629611
Efficacy and Safety Evaluation of Vi-sealer
Conditions: Benign Gynecologic Neoplasm
Sex: Female
Ages: 20 Years – 65 Years
Phase: NA
Enrollment: 280
Sponsor: Hyun Park
Location: Korea, Republic of
Summary
This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.
Eligibility Criteria
Inclusion Criteria:Aged 20 to 65 yearsClinically diagnosed with benign gynecologic neoplasms (eg.
adenomyosis, uterine fibroids, etc.)Eligible for hysterectomySigning an written consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedureExclusion Criteria:Large uterus size over 16 weeks of gestational ageCervical or intraligamentary fibroidsSevere endometriosis (stage 3 or 4)Suspected malignancy of the uterus or adnexaContraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)Previous pelvic surgery ≥ 3 timesNot suitable for laparoscopic surgery
Source: ClinicalTrials.gov (NCT05629611). StuddyBuddy aggregates publicly available trial information.