Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Mor… (NCT04392674) | Clinical Trial Compass
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Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation
China400 participantsStarted 2020-05-20
Plain-language 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 laparoscopic myomectomy morcellation
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation