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
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
Treatments tested in this trial
- Vi-Sealer
- Ligasure
- Other AHD
Treatment groups
280 Participants
are divided into 4 treatment groupsSponsors and collaborators
Hyun Park
Lead sponsor
CHA University
Sponsor institution
Source ClinicalTrials.gov