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Tests treatment safety and results for Benign Gynecologic Neoplasm
Official title Efficacy and Safety Evaluation of Vi-sealer
ClinicalTrials.gov ID: NCT05629611
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 65, women only
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, Gyeonggi-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, Gyeonggi-do, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.