ClinicalTrials.Veeva

Menu

Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation

J

Jing Liang

Status

Enrolling

Conditions

Gynecologic Surgery

Treatments

Device: the new tissue containment system

Study type

Interventional

Funder types

Other

Identifiers

NCT04392674
NTCS-20200508

Details and patient eligibility

About

The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation

Enrollment

400 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pre- and Peri-menopausal woman patient age 18-45 years

    • Women with fibroids and indication for laparoscopic myomectomy.
    • Normal Pap smear result within one year
    • MRI ( Magnatic Resonance Imaging ) or other imaging findings indicate the diameter of the largest uterine fibroids is between 4 to 10cm.
    • The body mass index of the patients is 18.5-27.9kg/m2
    • Signed informed consent form

Exclusion criteria

  • • Women with Known or suspected malignancy

    • patients with severe pelvic adhesion found during the operation
    • The body mass index of the patient ≥ 28kg/m2
    • Diameter of a single uterine fibroid>10cm
    • patients during pregnancy and lactation
    • Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient
    • Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit
    • Patients who are known to have participated in any other clinical trial within 3 months
    • Patients who cannot sign informed consent
    • Patients with acute stage infection of the reproductive system or other sites

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

400 participants in 1 patient group

using the new tissue containment system
Experimental group
Description:
using the new tissue containment system during Laparoscopic myomectomy morcellation
Treatment:
Device: the new tissue containment system

Trial contacts and locations

1

Loading...

Central trial contact

Yao Wang, PHD; Fang Zhao, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems