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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Uterine Fibroids (Leiomyoma)

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• China
  • No. 2, Xinghua East Street, Chaoyang District
    • Beijing, No. 2, Xinghua East Street, Chaoyang District, China, 100020
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes female patients with uterine fibroids undergoing laparoscopic myomectomy at a single center between April 2025 and March 2026. Eligible participants are women aged 28 to 46 years with fibroids measuring 6 to 10 cm in diameter and preoperative findings consistent with benign disease.

Description

Inclusion Criteria:

Female patients aged 28 to 46 years Diagnosis of uterine fibroids confirmed by pelvic ultrasound and magnetic resonance imaging (MRI) Maximum diameter of the dominant fibroid between 6 and 10 cm Scheduled to undergo laparoscopic myomectomy Preoperative evaluation consistent with benign uterine fibroids Able and willing to provide written informed consent

Exclusion Criteria:

Suspicion of uterine malignancy based on imaging findings or clinical assessment Presence of severe systemic disease contraindicating laparoscopic surgery Current pregnancy Inability or unwillingness to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Laparoscopic Myomectomy with Fully Enclosed Protective Device; This cohort includes women diagnosed with uterine fibroids who underwent laparoscopic myomectomy assisted by a fully enclosed protective device system designed to achieve tumor-free protection throughout the entire surgical procedure. During the operation, a specialized high-strength protective bag is introduced into the pelvic cavity before fibroid dissection. The fibroid is separated from the uterine wall while being supported and contained within the protective bag. After removal, the fibroid is completely isolated within the bag, and in-bag morcellation or tissue fragmentation is performed within a sealed environment with an independent pneumoperitoneum, preventing tissue or fluid leakage into the abdominal cavity. The intervention aims to maintain the oncological "tumor-free principle" throughout the procedure, reduce the risk of tissue dissemination, and improve surgical safety during laparoscopic myomectomy. Participants in this cohort were evaluated for surgical outcomes in

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bag integrity and absence of tissue leakage	Assessment of whether the protective bag remains intact without rupture or leakage during the procedure.	Intraoperative and immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Total duration of the surgical procedure	During surgery
Intraoperative blood loss	Estimated blood loss measured in milliliters	During surgery
Fibroid size	Maximum diameter of the removed uterine fibroid measured intraoperatively and confirmed by postoperative pathology	Immediately after surgical removal and confirmed by pathology
Postoperative hospital stay	Length of postoperative hospital stay measured in days	Perioperatively (from surgery up to hospital discharge, within 7 days)
Postoperative complications	Incidence of postoperative complications such as infection, fever, or pelvic inflammation	From the day of surgery through 30 days postoperatively
Histopathological diagnosis	Confirmation of the pathological type of removed fibroids by postoperative pathology	Immediately after surgical removal, confirmed by postoperative pathology

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Publications and helpful links

General Publications

• Kho KA, Nezhat C. Parasitic myomas. Obstetrics & Gynecology. 2009
• Cohen SL, Greenberg JA, Wang KC, et al. Risk of dissemination of occult uterine malignancy during laparoscopic morcellation. JAMA. 2014
• U.S. Food and Drug Administration. Quantitative Assessment of the Prevalence of Uterine Sarcoma in Women Undergoing Treatment of Uterine Fibroids. FDA Safety Communication.

Helpful Links

• General information about uterine fibroids and laparoscopic surgery
• China-Japan Friendship Hospital official website

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Estimated): March 4, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: 2024-KY-222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) from this study will not be publicly shared because the dataset contains identifiable clinical information from a small number of patients treated at a single institution. Public release of these data may increase the risk of patient re-identification and compromise participant privacy. In addition, the study was conducted as a retrospective analysis and the informed consent obtained from participants did not include permission for public sharing of individual-level data. Therefore, to protect patient confidentiality and comply with institutional ethics policies, IPD will not be made publicly available.

Study Data/Documents

1. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No