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Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation | Clinical Trials | Clareo Health

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

Safety and Efficacy of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Myomectomy Morcellation

NCT04392674•Jing Liang

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 45 years

Sex

FEMALE

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

Locations (1)

China-Japan Friendship Hospital

Beijing, China

Key Dates

Start Date

May 20, 2020

Primary Completion Date

December 1, 2022

Completion Date

December 20, 2022

Last Updated

October 26, 2022

Enrollment

400

ESTIMATED participants

Conditions

Gynecologic Surgery

Interventions

the new tissue containment system

DEVICE

Contacts

Fang Zhao, MD

CONTACT

861084206115 fangzhaow@163.com

Yao Wang, PHD

CONTACT

861084205983

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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