Efficacy and Safety Evaluation of Vi-sealer

Hyun Park

Status: Enrolling

Conditions: Benign Gynecologic Neoplasm

Treatments: Device: Ligasure; Device: Other AHD; Device: Vi-Sealer

Study type: Interventional

Funder types: Other

Identifiers

NCT05629611

KGOG4009_Vi-TLH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 4 patient groups

Study 1 Vi-Sealer

Experimental group

Description:

This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.

Treatment:

Device: Vi-Sealer

Study 1 Ligasure

Active Comparator group

Description:

This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.

Treatment:

Device: Ligasure

Study 2 Vi-sealer

Experimental group

Description:

This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.

Treatment:

Device: Vi-Sealer

Study 2 Other AHD

Active Comparator group

Description:

This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.

Treatment:

Device: Other AHD