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

NCT ID: NCT02957500

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-22

Study Completion Date

2017-07-31

Brief Summary

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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

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

Conditions

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Gynecologic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mediclore®

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

Group Type EXPERIMENTAL

Mediclore® (adhesion barrier)

Intervention Type DEVICE

No treatment

standard treatment for surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mediclore® (adhesion barrier)

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CGBio Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHA kangnam medical center, CHA university

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jihee Jang

Role: CONTACT

+82-2-550-8037

Facility Contacts

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Seok Ju Seong

Role: primary

Other Identifiers

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CG-AHS007

Identifier Type: -

Identifier Source: org_study_id

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