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

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