RecruitingNot Applicable

Efficacy and Safety Evaluation of Vi-sealer

South Korea280 participantsStarted 2023-01-20

Plain-language 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.

Who can participate

Age range20 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Operative procedure time

Timeframe: through study completion, an average of 1 year

Estimated blood loss

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05629611

SponsorHyun Park

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Hyun Park

+82-031-780-5640 p06162006@cha.ac.kr

View on ClinicalTrials.gov More Benign Gynecologic Neoplasm trials