Assessment of the antiadhesion efficacy of BioRegen® crosslinked hyaluronic acid gel in Laparoscopically Endometriosis Surgery - Pilot study - combination product trial - ACHYLES STUDY”

BioRegen Biomedical (Changzhou) Co., Ltd.0 个研究点目标入组 60 人开始时间: 2023年4月17日最近更新: 2024年8月19日

适应症

试验速览

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•Women aged 18-55
•Women willing, able to and having freely given written consent to participate in the study and abide its requirements.
•Women in good general health; including ASA (American Society of Anesthesiologists) score of 2 or less.
•- Women agree to a 3-step therapy for endometriosis
•- Subject not currently pregnant.
•Sexually active premenopausal women that agrees to not attempting pregnancy within 3 months after product application and agree to use a method of contraception.

•Subjects that meet the main inclusion criteria but attempting to get pregnant within 3 months of product application.
•Patients must be also excluded if they meet any of the following criteria
•Current pregnancy including ectopic pregnancy.
•Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation.
•History of cancer within the past 5 years (excluding breast cancer)
•History of heparin induced thrombocytopenia (HIT), or known sensitivity to heparin-like products.
•History of blood coagulation disorders
•Active pelvic or abdominal infection.
•Additional surgical procedure (non-OB/GYN) planned to be performed during the laparoscopic procedure (excluding appendectomy)
•Known or suspected allergy to hyaluronic acid

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