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NCT Number: NCT05629611

Efficacy and Safety Evaluation of 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.

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Key information

Conditions

Benign Gynecologic Neoplasm

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Location status: Recruiting

Location contact

Hyun Park

CONTACT

Min Jung Kim

CONTACT

[email protected]

+82-031-780-5640

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vi-Sealer

Device

using Reusable device, Vi-Sealer

LIGASURE

Device

using Ligasure

Other AHD

Device

Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure

Primary outcomes

  1. 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

  2. Estimated blood loss

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Estimated medical cost of device

    Time frame: within 6 weeks after intervention

    Medical costs according to hemostatic instrument use

  2. Device evaluation score

    Time frame: through study completion, an average of 1 year

    Ergonomics and subjective hemostatic performances assessed by surgeons using the survey

  3. Adverse events

    Time frame: within 6 weeks after intervention

    Collect only for adverse events that have a relationship with medical devices for clinical trials

Study contacts

Contact information is provided by the study sponsor or research team.

Hyun Park

CONTACT

[email protected]

+82-031-780-5640

Sponsors and collaborators

Lead sponsor

Hyun Park

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Nov 29, 2022
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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