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Search / Trial NCT05629611

Efficacy and Safety Evaluation of Vi-sealer

Launched by HYUN PARK · Nov 17, 2022

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Advanced Hemostatic Devices Advanced Energy Devices Ligasure Laparoscopic Total Hysterectomy Vi Sealer

ClinConnect Summary

This clinical trial is looking at a new device called Vi-Sealer, which is designed to help control bleeding during a specific type of surgery known as laparoscopic total hysterectomy. This surgery is performed on women who have benign gynecologic conditions, such as uterine fibroids or adenomyosis. The main goal of the study is to see if Vi-Sealer works better and is safer than traditional devices that are currently used for this purpose.

To participate in this study, women between the ages of 20 and 65 who have been diagnosed with benign gynecologic conditions and are planning to have a hysterectomy may be eligible. However, certain conditions may prevent participation, such as having a very large uterus, severe endometriosis, or previous surgeries. If you choose to participate, you will be asked to sign a consent form explaining the study's purpose and procedures. During the trial, participants can expect to undergo the surgery using the Vi-Sealer device and will be monitored for safety and effectiveness throughout the process.

Gender

FEMALE

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

About Hyun Park

Hyun Park is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on developing effective therapies across various therapeutic areas, the organization emphasizes rigorous methodologies and adherence to regulatory standards to ensure the safety and efficacy of clinical interventions. Leveraging a collaborative approach, Hyun Park partners with healthcare professionals, research institutions, and industry leaders to facilitate the successful execution of clinical trials, ultimately aiming to improve patient outcomes and contribute to the broader medical community.

Locations

Seongnam Si, Gyeonggi Do, Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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