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

Gynecologic Disease Clinical Trial

— antiadhesion  

Official title:

To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Intrauterine Surgery in Patient With Gynecological Disease, a Multicenter, Randomized, Double- Blinded Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02957500
• Other study ID #: CG-AHS007
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2016
• Last updated: March 26, 2017
• Start date: November 22, 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2016
• Source: CGBio Inc.
• Contact: Jihee Jang
• Phone: +82-2-550-8037
• Email: jhchang[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

Device:
• Mediclore® (adhesion barrier)

Locations

Country	Name	City	State
Korea, Republic of	CHA kangnam medical center, CHA university	Seoul City

Sponsors (1)

Lead Sponsor	Collaborator
CGBio Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhesion incidence rate following 4 weeks		4weeks