Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
CHA Bundang Medical Center
RECRUITING
Seongnam-si
Contact Information
Primary
Hyun Park
p06162006@cha.ac.kr
+82-031-780-5640
Time Frame
Start Date: 2023-01-20
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 280
Treatments
Experimental: Study 1 Vi-Sealer
This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
Active_comparator: Study 1 Ligasure
This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.
Experimental: Study 2 Vi-sealer
This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
Active_comparator: Study 2 Other AHD
This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.
Related Therapeutic Areas
Sponsors
Leads: Hyun Park