Efficacy and Safety Evaluation of Vi-sealer

Not Applicable

Recruiting

• Conditions: Benign Gynecologic Neoplasm
• Interventions: Device: Ligasure; Device: Vi-Sealer; Device: Other AHD

• Registration Number: NCT05629611
• Lead Sponsor: Hyun Park

Brief 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.

Study Timeline

• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Study Start: 2023-01-20
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2024-12
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study 1 Ligasure	Ligasure	This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.
Study 2 Vi-sealer	Vi-Sealer	This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
Study 2 Other AHD	Other AHD	This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.
Study 1 Vi-Sealer	Vi-Sealer	This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.

Primary Outcome Measures

Name	Time	Method
Estimated blood loss	through study completion, an average of 1 year
Operative procedure time	through study completion, an average of 1 year	Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites

Secondary Outcome Measures

Name	Time	Method
Device evaluation score	through study completion, an average of 1 year	Ergonomics and subjective hemostatic performances assessed by surgeons using the survey
Adverse events	within 6 weeks after intervention	Collect only for adverse events that have a relationship with medical devices for clinical trials
Estimated medical cost of device	within 6 weeks after intervention	Medical costs according to hemostatic instrument use

Trial Locations

Locations (1)

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of