RecruitingNot ApplicableNCT05629611
Efficacy and Safety Evaluation of Vi-sealer
Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
Sponsor
Hyun Park
Enrollment
280 participants
Start Date
Jan 20, 2023
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 20 YearsMax Age: 65 Years
Inclusion Criteria4
- Aged 20 to 65 years
- Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.)
- Eligible for hysterectomy
- Signing 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 procedure
Exclusion Criteria7
- Large uterus size over 16 weeks of gestational age
- Cervical or intraligamentary fibroids
- Severe endometriosis (stage 3 or 4)
- Suspected malignancy of the uterus or adnexa
- Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)
- Previous pelvic surgery ≥ 3 times
- Not suitable for laparoscopic surgery
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Interventions
DEVICEVi-Sealer
using Reusable device, Vi-Sealer
DEVICELigasure
using Ligasure
DEVICEOther AHD
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05629611