Clinical trial NCT05629611: Efficacy and Safety Evaluation of Vi-sealer
Official title: Efficacy and Safety Evaluation of Advanced Vessel Sealing Device (Vi-sealer)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Gynecologic Neoplasm
Keywords: Advanced hemostatic devices
Advanced energy devices
Ligasure
Laparoscopic total hysterectomy
Vi-sealer
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 280
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Operative procedure time
timeFrame: through study completion, an average of 1 year
measure: Estimated blood loss
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Estimated medical cost of device
timeFrame: within 6 weeks after intervention
measure: Device evaluation score
timeFrame: through study completion, an average of 1 year
measure: Adverse events
timeFrame: within 6 weeks after intervention
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
References:
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