Efficacy and Safety Evaluation of Vi-sealer
Launched by HYUN PARK · Nov 17, 2022
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seongnam Si, Gyeonggi Do, Korea, Republic Of
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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