Back to resultsEfficacy and Safety Evaluation of Vi-sealer
Primary Purpose
Benign Gynecologic Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vi-Sealer
Ligasure
Other AHD
Sponsored by
About this trial
This is an interventional treatment trial for Benign Gynecologic Neoplasm focused on measuring Advanced hemostatic devices, Advanced energy devices, Ligasure, Laparoscopic total hysterectomy, Vi-sealer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers) Previous pelvic surgery ≥ 3 times Not suitable for laparoscopic surgery
Sites / Locations
- CHA Bundang Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Study 1 Vi-Sealer
Study 1 Ligasure
Study 2 Vi-sealer
Study 2 Other AHD
Arm Description
This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.
This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.
Outcomes
Primary Outcome Measures
Operative procedure time
Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites
Estimated blood loss
Secondary Outcome Measures
Estimated medical cost of device
Medical costs according to hemostatic instrument use
Device evaluation score
Ergonomics and subjective hemostatic performances assessed by surgeons using the survey
Adverse events
Collect only for adverse events that have a relationship with medical devices for clinical trials
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05629611
Brief Title
Efficacy and Safety Evaluation of Vi-sealer
Official Title
Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hyun Park
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed Description
Vi-Sealer is a reusable advanced bipolar electrode with an interchangeable blade. This study evaluates the efficacy and safety of the Vi-Sealer by comparing it with other advanced hemostatic devices, such as Ligasure, Enseal, Thunderbeat, Harmonic scalpel, etc. The economic evaluation of the device compared with other disposable devices would also be conducted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Gynecologic Neoplasm
Keywords
Advanced hemostatic devices, Advanced energy devices, Ligasure, Laparoscopic total hysterectomy, Vi-sealer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study 1 Vi-Sealer
Arm Type
Experimental
Arm Description
This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
Arm Title
Study 1 Ligasure
Arm Type
Active Comparator
Arm Description
This group of women undergoing hysterectomy is randomized to the energy device, Ligasure.
Arm Title
Study 2 Vi-sealer
Arm Type
Experimental
Arm Description
This group of women undergoing hysterectomy is randomized to the energy device, Vi-sealer.
Arm Title
Study 2 Other AHD
Arm Type
Active Comparator
Arm Description
This group of women undergoing hysterectomy is randomized to energy devices other than Ligasure.
Intervention Type
Device
Intervention Name(s)
Vi-Sealer
Intervention Description
using Reusable device, Vi-Sealer
Intervention Type
Device
Intervention Name(s)
Ligasure
Intervention Description
using Ligasure
Intervention Type
Device
Intervention Name(s)
Other AHD
Intervention Description
Using other AHDs such as Thunderbeat, Harmonic scalpel, Caiman®, Enseal, etc. except Ligasure
Primary Outcome Measure Information:
Title
Operative procedure time
Description
Measure the time consumed from the initial skin incision to the closure of abdominal trocar sites
Time Frame
through study completion, an average of 1 year
Title
Estimated blood loss
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Estimated medical cost of device
Description
Medical costs according to hemostatic instrument use
Time Frame
within 6 weeks after intervention
Title
Device evaluation score
Description
Ergonomics and subjective hemostatic performances assessed by surgeons using the survey
Time Frame
through study completion, an average of 1 year
Title
Adverse events
Description
Collect only for adverse events that have a relationship with medical devices for clinical trials
Time Frame
within 6 weeks after intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)
Previous pelvic surgery ≥ 3 times
Not suitable for laparoscopic surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Park
Phone
+82-031-780-5640
Email
p06162006@cha.ac.kr
Facility Information:
Facility Name
CHA Bundang Medical Center
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Jung Kim
Phone
+82-031-780-5640
Email
tooncrunch@naver.com
First Name & Middle Initial & Last Name & Degree
Hyun Park
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Efficacy and Safety Evaluation of Vi-sealer
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