Efficacy and Safety Evaluation of Vi-sealer

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0008008
• Lead Sponsor: Bundang CHA General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

1. Aged 20 to 65 years
2. Clinically diagnosed with benign gynecologic neoplasms (eg.
adenomyosis, uterine fibroids, etc.)
3. Eligible for hysterectomy
4. 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

1. Large uterus size over 16 weeks of gestational age
2. Cervical or intraligamentary fibroids
3. Severe endometriosis (stage 3 or 4)
4. Suspected malignancy of the uterus or adnexa
5. Contraindicated for the use of energy devices (such as implantable
cardioverter defibrillators, pacemakers)
6. Previous pelvic surgery = 3 times
7. Not suitable for laparoscopic surgery

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Operative procedure time;Estimated blood loss

Secondary Outcome Measures

Name	Time	Method
Economic evaluation;Device evaluation score;Adverse events