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Active, Not Recruiting

NCT Number: NCT07474688

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Uterine Fibroids (Leiomyoma) Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

28 year–46 year

Sex eligibility

Female

Study type

Observational

Primary location

China-Japan Friendship Hospital

Beijing, No. 2, Xinghua East Street, Chaoyang District, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bag integrity and absence of tissue leakage

    Time frame: Intraoperative and immediately after surgery

    Assessment of whether the protective bag remains intact without rupture or leakage during the procedure.

Secondary outcomes

  1. Operative time

    Time frame: During surgery

    Total duration of the surgical procedure

  2. Intraoperative blood loss

    Time frame: During surgery

    Estimated blood loss measured in milliliters

  3. Fibroid size

    Time frame: Immediately after surgical removal and confirmed by pathology

    Maximum diameter of the removed uterine fibroid measured intraoperatively and confirmed by postoperative pathology

  4. Postoperative hospital stay

    Time frame: Perioperatively (from surgery up to hospital discharge, within 7 days)

    Length of postoperative hospital stay measured in days

  5. Postoperative complications

    Time frame: From the day of surgery through 30 days postoperatively

    Incidence of postoperative complications such as infection, fever, or pelvic inflammation

  6. Histopathological diagnosis

    Time frame: Immediately after surgical removal, confirmed by postoperative pathology

    Confirmation of the pathological type of removed fibroids by postoperative pathology

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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