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

NCT ID: NCT03007654

Last Updated: 2017-01-05

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

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-08-31

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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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

SINGLE

Participants

Study Groups

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Mediclore

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

Group Type EXPERIMENTAL

Mediclore

Intervention Type DEVICE

apply medical device fully around intrauterine surgery area

No treatment

standard treatment for surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Adept

adhesion barrier, Adept, to apply medical device fully around surgery area

Group Type ACTIVE_COMPARATOR

Adept

Intervention Type DEVICE

apply medical device fully around intrauterine surgery area

Interventions

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Mediclore

apply medical device fully around intrauterine surgery area

Intervention Type DEVICE

Adept

apply medical device fully around intrauterine surgery area

Intervention Type DEVICE

Other Intervention Names

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Poloxamer, Gelatin and Chitosan.

Eligibility Criteria

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Inclusion Criteria

* Patients with Gynecological disease (benign disease)
* Patients who 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
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
* Patients with previous history of surgery at the same operate site
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yong Sang Song

OTHER

Sponsor Role lead

Responsible Party

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Yong Sang Song

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Seoutl National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yongsang Song, MD

Role: CONTACT

+82-10-9580-1023

Maria Lee, MD

Role: CONTACT

+82-10-2991-9692

Facility Contacts

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Yong sang Song, MD

Role: primary

+82-10-9580-1023

Maria Lee, MD

Role: backup

+82-10-2991-9692

Other Identifiers

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CG-AHS008

Identifier Type: -

Identifier Source: org_study_id

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