A prospective, non-randomized, open label, multi-center, single arm study to demonstrate the safety of LionessÂ© pessary PregnanTech Ltd, in female patients undergoing total hysterectomy for various benign conditions.

PregnanTech Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Female subjects before menopause, aged 20 to 45 years, both inclusive.
•2. Subjects undergoing planned total hysterectomy (including full length of the cervix) either total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) for various benign indications.
•3. Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan.
•4. Subject whose screening laboratory values are within normal range or are considered clinically not significant by the Principal Investigator
•5. Subjects with history of previous delivery(ies)
•6. Subjects with negative serum pregnancy test at screening.

•1. Subjects undergoing subtotal hysterectomy, not including the cervix
•2. Subjects with low fibroids close to the cervix
•3. Subjects undergoing hysterectomy for malignancy
•4. History of cervical intraepithelial neoplasia (CIN) or cervical cancer
•5. History of cervical conization
•6. Subjects with an IUD
•7. Subjects with positive test for HIV, HBV or HCV
•8. Subjects with history of tuberculosis affecting the reproductive organs
•9. History of cervicitis, vaginitis or vaginal ulcerative disease
•10. Vaginismus
•11. Subjects with bleeding disorders (excluding menorrhagia or metrorrhagia)
•12. Known sensitivity, contraindication or intolerance to silicone
•13. Has a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the CIP
•14. Subject is currently participating or has participated in another clinical trial within the past 30 days prior to screening
•15. Any coexisting serious or uncontrolled comorbid condition.

发起方

PregnanTech Ltd