DRKS00023649CompletedPhase 4
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 sites60 target enrollmentStarted: April 17, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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