NCT07474688

Laparoscopic Myomectomy Based on a Fully Enclosed Protective Device: A Novel Surgical Technique Achieving Tumor-Free Protection Throughout the Entire Procedure

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: Female
• Age: 28 Years – 46 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to evaluate the feasibility, safety, and effectiveness of a fully enclosed protective device system in laparoscopic myomectomy to achieve tumor-free protection throughout the entire surgical procedure in women aged 28-46 years diagnosed with uterine fibroids who require laparoscopic myomectomy. The main questions it aims to answer are: Can the fully enclosed protective device system successfully achieve complete physical isolation of fibroid tissue during laparoscopic myomectomy and morcellation? Does the use of this device reduce the risk of tissue dissemination or leakage while maintaining acceptable surgical outcomes such as operative time, blood loss, and postoperative recovery? Participants will undergo laparoscopic myomectomy assisted by the fully enclosed protective device system. During the procedure, participants will: undergo laparoscopic removal of uterine fibroids using a fully enclosed protective isolation system have the fibroid dissected and contained within a protective bag during the entire procedure receive in-bag morcellation or fragmentation of fibroid tissue within a sealed environment be evaluated for operative outcomes including fibroid size, operative time, intraoperative blood loss, integrity of the protective bag, and postoperative hospital stay

Conditions

• Uterine Fibroids (Leiomyoma)

Timeline

• Start date: 2025-04-04
• Primary completion: 2026-03-01
• Completion: 2026-03-04
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China