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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02957500

Acronym

antiadhesion

Enrollment

198

Registered

2016-11-07

Start date

2016-11-22

Completion date

2017-07-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Disease

Brief 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.

Detailed description

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

Interventions

DEVICEMediclore® (adhesion barrier)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Adhesion incidence rate following 4 weeks	4weeks

Countries

South Korea

Contacts

Primary ContactJihee Jang

jhchang@daewoong.co.kr+82-2-550-8037

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026