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Trial Title:
Efficacy and Safety Evaluation of Vi-sealer
NCT ID:
NCT05629611
Condition:
Benign Gynecologic Neoplasm
Conditions: Official terms:
Genital Neoplasms, Female
Conditions: Keywords:
Advanced hemostatic devices
Advanced energy devices
Ligasure
Laparoscopic total hysterectomy
Vi-sealer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Vi-Sealer
Description:
using Reusable device, Vi-Sealer
Arm group label:
Study 1 Vi-Sealer
Arm group label:
Study 2 Vi-sealer
Intervention type:
Device
Intervention name:
Ligasure
Description:
using Ligasure
Arm group label:
Study 1 Ligasure
Intervention type:
Device
Intervention name:
Other AHD
Description:
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except
Ligasure
Arm group label:
Study 2 Other AHD
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 20 to 65 years
2. Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine
fibroids, etc.)
3. Eligible for hysterectomy
4. 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 Criteria:
1. Large uterus size over 16 weeks of gestational age
2. Cervical or intraligamentary fibroids
3. Severe endometriosis (stage 3 or 4)
4. Suspected malignancy of the uterus or adnexa
5. Contraindicated for the use of energy devices (such as implantable cardioverter
defibrillators, pacemakers)
6. Previous pelvic surgery ≥ 3 times
7. Not suitable for laparoscopic surgery
Gender:
Female
Minimum age:
20 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHA Bundang Medical Center
Address:
City:
Seongnam-si
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Min Jung Kim
Phone:
+82-031-780-5640
Email:
tooncrunch@naver.com
Contact backup:
Last name:
Hyun Park
Start date:
January 20, 2023
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Hyun Park
Agency class:
Other
Source:
CHA University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05629611
