ltrasound-guided transvaginal radiofrequency ablation of uterine fibroids performance evaluation of GYIDE - NI

esa Medtech Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1.Women in reproductive age who have completed family planning with symptomatic uterine fibroid (menorrhagia, heavy menstrual bleeding) for at least 2 months and as confirmed by USG.
•2.Patients presenting with 1-4 fibroids of FIGO types 2, 3, 4, and/or type 2-5, with diameter of 1.0 cm and up-to 6.0 cm.
•3.No desire for future fertility
•4.Women willing to provide informed consent for participation in the study and willing to undergo this RFA using (GYIDE) and adhere to follow-up requirements

•1.Presence of a single polyp less than 1.5 cm, or multiple polyps of any size, within the uterine cavity.
•2.Any abnormality of the endometrial cavity that obstructs access of the handpiece
•3.Total uterine volume more than 1000 cc.
•4.Pregnancy.
•5.Presence of type 0 fibroids, unless greater than 1 cm in diameter.
•6.Presence of an extrauterine pelvic mass that has not been diagnosed as benign.
•7.Multiple uterine scars.
•8.Congenital uterine abnormality
•9.Previous procedure for fibroids or heavy menstrual bleeding other than myomectomy (example: endometrial ablation).
•10.Confirmed abdominal or pelvic malignancy within the previous five years
•11.Active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia, UTI.

发起方

esa Medtech Private Limited