Intrauterine Adhesion Clinical Trial
Official title:
A Prospective, Multi-center, Randomized, Controlled Clinical Study on Self-crosslinked Sodium Hyaluronate Gel for Prevention of Intrauterine Adhesion
Intrauterine adhesion (IUA) is the adhesion of intrauterine tissues due to the exposure of
myometrial tissues caused by the endometrial basal injury. IUA is clinically manifested as
symptoms such as abdominal pain, hypomenorrhea or amenorrhea, sterility and habitual
abortion, which seriously affect the patients quality of life.
Preventing IUA has been tried using different methods such as barrier or stent in order to
separate the opposing endometrium during the tissue healing processes. Although some
successes have been reported there are still some challenges need to be dealt with.
One of the barrier materials for preventing IUA is made of hyaluronic acid (HA). HA is a
natural ECM of human tissue with excellent biocompatibility and promotes the scar-free wound
repair. The self-crosslinked esterified HA gel has demonstrated the capacity to prevent IUA
in clinical studies.
A novel self-crosslinked HA gel is developed by BioRegen Biomedical(Changzhou)Co., Ltd with
proprietary technologies. This product is a highly viscoelastic crosslinked gel that
overcomes the shortcoming of sodium hyaluronate with high motility and too quick degradation
in vivo. For this product, the results of animal experiments and various safety features
have been designed and tested conforming to the national regulations and standards. In order
to launch this product to the market, this prospective, randomized and controlled clinical
trial is designed and will be performed to verify its safety/efficacy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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