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

NCT07474688 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-03-16

No results posted yet for this study

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)

Sponsors & Collaborators

  • China-Japan Friendship Hospital

    lead OTHER

Eligibility

Min Age
28 Years
Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-04
Primary Completion
2026-03-01
Completion
2026-03-04

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07474688 on ClinicalTrials.gov