Health TrialsbyHealthPanel

Efficacy and Safety Evaluation of Vi-sealer

ConditionBenign Gynecologic Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-65
SponsorHyun Park

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

280 Participants
are divided into 4 treatment groups
Group A: Study 1 Vi-SealerExperimental treatment 1 intervention
Group B: Study 1 LigasureActive comparator 1 intervention
Group C: Study 2 Vi-sealerExperimental treatment 1 intervention
Group D: Study 2 Other AHDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Operative procedure time

Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites

Time frame
through study completion, an average of 1 year
2

Estimated blood loss

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Estimated medical cost of device

Medical costs according to hemostatic instrument use

Time frame
within 6 weeks after intervention
2

Device evaluation score

Ergonomics and subjective hemostatic performances assessed by surgeons using the survey

Time frame
through study completion, an average of 1 year
3

Adverse events

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

Time frame
within 6 weeks after intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hyun Park

Lead sponsor

CHA University

Sponsor institution

Source ClinicalTrials.gov
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