Efficacy and Safety Evaluation of Vi-sealer

Hyun Park280 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

280

Conditions

Benign Gynecologic Neoplasm

Interventions

Vi-SealerDEVICE

using Reusable device, Vi-Sealer

LigasureDEVICE

using Ligasure

Other AHDDEVICE

Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

Operative procedure time

Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites

Time frame: through study completion, an average of 1 year

Estimated blood loss

Time frame: through study completion, an average of 1 year

Secondary Outcomes

Estimated medical cost of device

Medical costs according to hemostatic instrument use

Time frame: within 6 weeks after intervention

Device evaluation score

Ergonomics and subjective hemostatic performances assessed by surgeons using the survey

Time frame: through study completion, an average of 1 year

Adverse events

Collect only for adverse events that have a relationship with medical devices for clinical trials

Time frame: within 6 weeks after intervention

Central Contacts

Hyun Park

CONTACT

+82-031-780-5640 p06162006@cha.ac.kr

Data from ClinicalTrials.gov

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