Comparing the Vi-Sealer device to traditional hemostatic devices in laparoscopic hysterectomy
Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
This study is testing a new device called the Vi-Sealer to see if it works better and is safer than traditional devices during laparoscopic hysterectomy for women with certain gynecologic conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | Female |
| Sponsor | CHA University Academic / other |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT05629611 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of the Vi-Sealer, a novel advanced hemostatic device, in comparison to conventional advanced hemostatic devices during laparoscopic total hysterectomy for patients with benign gynecologic neoplasms. The study involves patients aged 20 to 65 who are clinically diagnosed with conditions such as adenomyosis or uterine fibroids and are eligible for hysterectomy. Participants will be monitored for outcomes related to safety and effectiveness, and an economic evaluation will also be conducted to assess the cost-effectiveness of the Vi-Sealer compared to other devices.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 to 65 with clinically diagnosed benign gynecologic neoplasms who are eligible for laparoscopic hysterectomy.
Not a fit: Patients with large uterine sizes, severe endometriosis, or those who are not suitable for laparoscopic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing laparoscopic hysterectomy.
How similar studies have performed: Other studies have shown success with advanced hemostatic devices, but the Vi-Sealer represents a novel approach in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seongnam-si, Gyeonggi-do
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Hyun Park
- Email: p06162006@cha.ac.kr
- Phone: +82-031-780-5640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.