Status:
UNKNOWN
Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Ovary Neoplasm
Surgery
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The study is designed to evaluate the safety, effectiveness and operability of performing in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic ovarian cystecto...
Eligibility Criteria
Inclusion
- Premenopausal woman patient age 18-45 years
- Women with regular period
- Women with ovarian neoplasm (size: 3-10cm)
- Laparoscopic surgery required
- Body mass index 18.5-27.9kg/m2
- Subject able to comprehend and give informed consent for participation in this study
- Signed informed consent form
Exclusion
- Patient is not considered suitable for a laparoscopic ovarian cystectomy procedure
- The ovaries and pelvic cavity are severely adhered, and the tumor ruptures when free
- Women with Polycystic ovary syndrome
- Baseline AMH less than 0.5ng / mL
- Known to have participated in any other clinical trials or hormone therapy within 3 months
- Women during pregnancy and lactation
- Women in acute stage infection of reproductive system or other parts
- Women combined with severe central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine metabolism (thyroid disease, Cushing syndrome, hyperprolactinemia) and skeletal muscle system and mental disorders contraindicating laparoscopic surgery
- Women with known or suspected poor compliance who cannot complete the trial
- Those who can not sign the informed consent
Key Trial Info
Start Date :
May 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04406597
Start Date
May 20 2022
End Date
December 10 2024
Last Update
October 26 2022
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 086010