NCT05629611

Efficacy and Safety Evaluation of Vi-sealer

Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Hyun Park · Academic / Other
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Vi-Sealer is a reusable advanced bipolar electrode with an interchangeable blade. This study evaluates the efficacy and safety of the Vi-Sealer by comparing it with other advanced hemostatic devices, such as Ligasure, Enseal, Thunderbeat, Harmonic scalpel, etc. The economic evaluation of the device compared with other disposable devices would also be conducted.

Conditions

• Benign Gynecologic Neoplasm

Interventions

Type	Name	Description
DEVICE	Vi-Sealer	using Reusable device, Vi-Sealer
DEVICE	Ligasure	using Ligasure
DEVICE	Other AHD	Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure

Timeline

• Start date: 2023-01-20
• Primary completion: 2024-12-01
• Completion: 2025-10-31
• First posted: 2022-11-29
• Last updated: 2024-10-01

Locations

1 site across 1 country: South Korea