Efficacy and Safety Evaluation of Vi-sealer

Sponsor

Hyun Park (Other)

Overall Status

Recruiting

CT.gov ID

NCT05629611

Collaborator

(none)

280

Enrollment

Location

Arms

35.4

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Gynecologic Neoplasm	Device: Vi-Sealer Device: Ligasure Device: Other AHD	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)

Anticipated Study Start Date :

Nov 20, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study 1 Vi-Sealer This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.	Device: Vi-Sealer using Reusable device, Vi-Sealer
Active Comparator: Study 1 Ligasure This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.	Device: Ligasure using Ligasure
Experimental: Study 2 Vi-sealer This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.	Device: Vi-Sealer using Reusable device, Vi-Sealer
Active Comparator: Study 2 Other AHD This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.	Device: Other AHD Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure

Outcome Measures

Primary Outcome Measures

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
Estimated blood loss [through study completion, an average of 1 year]

Secondary Outcome Measures

Estimated medical cost of device [within 6 weeks after intervention]
Medical costs according to hemostatic instrument use
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 20 to 65 years
Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.)
Eligible for hysterectomy
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:

Large uterus size over 16 weeks of gestational age
Cervical or intraligamentary fibroids
Severe endometriosis (stage 3 or 4)
Suspected malignancy of the uterus or adnexa
Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)
Previous pelvic surgery ≥ 3 times
Not suitable for laparoscopic surgery