Efficacy and Safety Evaluation of Vi-sealer

February 6, 2024 updated by: Hyun Park

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:
        • Principal Investigator:
          • Hyun Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative procedure time
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyun Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG4009_Vi-TLH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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