NCT02220621

Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion

A Prospective, Multi-center, Randomized, Controlled Clinical Study on Self-crosslinked Sodium Hyaluronate Gel for Prevention of Intrauterine Adhesion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Xiaozheng Shu · Industry
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intrauterine Adhesion

Interventions

Type	Name	Description
DEVICE	Crosslinked hyaluronic acid gel	After hysteroscopic adhesiolysis, MateRegen Gel IU is applied into the uterine cavity together with a Foley balloon catheter.
DEVICE	Foleys balloon catheter	After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-04-01
• First posted: 2014-08-20
• Last updated: 2014-08-20

Locations

3 sites across 1 country: China