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Efficacy and Safety Evaluation of Vi-sealer

RECRUITINGN/ASponsored by Hyun Park
Actively Recruiting
PhaseN/A
SponsorHyun Park
Started2023-01-20
Est. completion2024-12
Eligibility
Age20 Years – 65 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05629611

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

Age: 20 Years – 65 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions2

Benign Gynecologic NeoplasmCancer

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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