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Efficacy and Safety Evaluation of Vi-sealer

NCT05629611 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

  • Benign Gynecologic Neoplasm

Interventions

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

Sponsors & Collaborators

  • Hyun Park

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2024-12-31
Completion
2025-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629611 on ClinicalTrials.gov