Post-market surveillance study on SRS Implant - PMCFU SRS Implant

pfm medical ag0 个研究点目标入组 174 人开始时间: 2019年8月28日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patients older than 21 years suffering from symptomatic anterior vaginal and apical Prolapse (POP = stage II).

•Exclusion criteria result from the contraindications listed in the manufacturer’s IFU based on their technical documentation. The SRS Implant is contraindicated for use in any patient in whom soft tissue implants are contraindicated. In addition, patients with:
•Pathology of the pelvic soft tissue;
•Pregnant patients, or patients that are considering future pregnancies;
•Any pathology, including known or suspected uterine/cervical/vaginal/bladder pathology, which would compromise placement (e.g. anatomical distortion or abnormalities);
•Any pathology that would limit blood supply and compromise healing (e.g. decreased blood supply to organs because of treatments such as radiation therapy, chemotherapy);
•Presence of known or suspected cancer of the vagina, cervix, bladder or uterus;
•Blood coagulation disorder;
•Autoimmune connective tissue disease;
•Renal insufficiency and urinary tract obstruction;
•Pre-existing local or systemic infection (note: treat the infection with the appropriate antiseptics and/or antibiotics to eliminate the infection before placing the SRS Implant);
•And sensitivity/allergy to polypropylene or titanium-dioxide or polyether ether ketone (PEEK).
•Furthermore, patients with a mesh already implanted are excluded.

发起方

pfm medical ag