Efficacy and Safety Evaluation of Vi-sealer

Recruiting now · Not applicable

Conditions studied: Benign Gynecologic Neoplasm

In brief

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.

Key facts

Study ID

NCT05629611

Run by

Hyun Park

People needed

280

Starts

2023-01-20

Expected to finish

2025-10-31

Last updated by the study team

2024-10-01

Who can join

Age: 20 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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