Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation
NCT ID: NCT04392674
Last Updated: 2022-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2020-05-20
2022-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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using the new tissue containment system
using the new tissue containment system during Laparoscopic myomectomy morcellation
the new tissue containment system
using the new tissue containment system during Laparoscopic myomectomy morcellation
Interventions
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the new tissue containment system
using the new tissue containment system during Laparoscopic myomectomy morcellation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Jing Liang
OTHER
Responsible Party
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Jing Liang
professor
Locations
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China-Japan Friendship Hospital
Beijing, , China
Countries
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Central Contacts
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Yao Wang, PHD
Role: CONTACT
Facility Contacts
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Fang Zhao
Role: primary
Other Identifiers
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NTCS-20200508
Identifier Type: -
Identifier Source: org_study_id
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