Actively Recruiting

Phase Not Applicable
Age: 20Years - 65Years
FEMALE
NCT05629611

Efficacy and Safety Evaluation of Vi-sealer

Led by Hyun Park · Updated on 2024-10-01

280

Participants Needed

1

Research Sites

145 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy and Safety Evaluation of Vi-sealer

Who Can Participate

Age: 20Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 20 to 65 years
  • Clinically diagnosed with benign gynecologic neoplasms (e.g., adenomyosis, uterine fibroids)
  • Eligible for hysterectomy
  • Signed a written consent form indicating understanding of the study and willingness to participate
Not Eligible

You will not qualify if you...

  • Uterus size larger than 16 weeks of gestational age
  • Presence of cervical or intraligamentary fibroids
  • Severe endometriosis (stage 3 or 4)
  • Suspected malignancy of the uterus or adnexa
  • Contraindications to energy devices (e.g., implantable cardioverter defibrillators, pacemakers)
  • Previous pelvic surgery three or more times
  • Not suitable for laparoscopic surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Actively Recruiting

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Research Team

H

Hyun Park

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Efficacy and Safety Evaluation of Vi-sealer | DecenTrialz