Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy

China-Japan Friendship Hospital

Status

Enrolling

Conditions

Surgery

Ovary Neoplasm

Treatments

Device: the New Tissue Containment System

Study type

Interventional

Funder types

Other

Identifiers

NCT04406597

NTCS-LOC

Details and patient eligibility

About

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 cystectomy. Premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.

Enrollment

400 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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