Status:
UNKNOWN
Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation
Lead Sponsor:
Jing Liang
Conditions:
Gynecologic Surgery
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
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 laparosco...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2022
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04392674
Start Date
May 20 2020
End Date
December 20 2022
Last Update
October 26 2022
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, China