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

CGBio

Status: Unknown

Conditions: Gynecologic Disease

Treatments: Device: Mediclore® (adhesion barrier)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02957500

CG-AHS007

Details and patient eligibility

About

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.

Full description

to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier

Enrollment: 198 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the patients with submucosal myomas, endometrial polyps, intra-uterine adhesion, uterine septa, dysfunctional uterine bleeding
• Written informed consent
• Patients without clinically significant lab

Exclusion criteria

• having enrolled another clinical trials within 1 month
• Immunosuppression or autoimmune disease
• Anticoagulant, general steroids within a week from surgery
• Incompatible medications
• Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

Mediclore®

Experimental group

Description:

adhesion barrier Mediclore 5cc, to apply medical device fully around intrauterine surgery area

Treatment:

Device: Mediclore® (adhesion barrier)

No treatment

No Intervention group

Description:

standard treatment for surgery