NCT03007654

Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)

Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Yong Sang Song · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.

Conditions

• Gynecologic Disease

Interventions

Type	Name	Description
DEVICE	Mediclore	apply medical device fully around intrauterine surgery area
DEVICE	Adept	apply medical device fully around intrauterine surgery area

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2017-01-02
• Last updated: 2017-01-05

Locations

1 site across 1 country: South Korea