Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Actively Recruiting
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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