Efficacy and Safety Evaluation of Vi-sealer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Benign Gynecologic Neoplasm

Intervention / Treatment
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* Device: Vi-Sealer
* Device: Ligasure
* Device: Other AHD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated medical cost of device | Medical costs according to hemostatic instrument use | within 6 weeks after intervention | 
| Device evaluation score | Ergonomics and subjective hemostatic performances assessed by surgeons using the survey | 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 | within 6 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced hemostatic devices, Advanced energy devices, Ligasure, Laparoscopic total hysterectomy, Vi-sealer