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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04392674
Other study ID # NTCS-20200508
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 20, 2020
Est. completion date December 20, 2022

Study information

Verified date October 2022
Source China-Japan Friendship Hospital
Contact Fang Zhao, MD
Phone 861084206115
Email fangzhaow@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 20, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
the new tissue containment system
using the new tissue containment system during Laparoscopic myomectomy morcellation

Locations

Country Name City State
China China-Japan Friendship Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Jing Liang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The safety of using the new tissue containment system for contained cutting and extracting tissue during laparoscopic myomectomy morcellation The safety of using the new tissue containment system for cutting and extracting tissue during laparoscopic myomectomy morcellation will be determined by the rate of leakage
Leakage is defined as "disruption of the device (using dye leak testing) or visible tissue dissemination.
approximately two years
Secondary The probability of failure during in-bag morcellation procedure Failure is defined as the operator's inability to successfully insert and extract the device. approximately two years
Secondary Mean procedure time Mean procedure time will be measured by hour/minutes. approximately two years
Secondary Estimated blood loss during operation Blood loss during operation will be measured by volume (mL) approximately two years
Secondary Post-operative pain Post-operative pain will be measured by Visual Analog Score - VAS approximately two years
Secondary Intra- or post-operative complications Intra or post complications rate (e.g. urinary, intestinal or nerve injury) approximately two years
Secondary The Surgeon Task Load Index The Surgeon Task Load Index be measured by designated Questionnaire. approximately two years
Secondary The Patients' life quality postoperative The Patients' life quality postoperative be measured by Questionnaire. approximately two years
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