Clinical Trial to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
NCT ID: NCT02940210
Last Updated: 2016-10-20
Study Results
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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UNKNOWN
PHASE3
172 participants
INTERVENTIONAL
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Mediclore®
adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy
Mediclore® (adhesion barrier)
No treatment
No treatment, standard treatment for thyroidectomy
No interventions assigned to this group
Interventions
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Mediclore® (adhesion barrier)
Eligibility Criteria
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Inclusion Criteria
* Male or female at least 20 years of age
* Patients without clinically significant lab
* Patients scheduled for thyroidectomy
Exclusion Criteria
* History of previous surgery on same position
* Anticoagulant, general steroids within a week from surgery
* Immunosuppression or autoimmune disease
* General or local infection
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
* Incompatible medications
* History of drug or alcohol abuse, mental disorder
* Pregnant or lactating women and fertile women who is not using proper contraceptive method
* History of esophagus diseases
* Keloid symptoms
20 Years
ALL
No
Sponsors
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CGBio Inc.
INDUSTRY
Responsible Party
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Locations
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Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Ha Eun Lee
Role: primary
Other Identifiers
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CG-AHS004
Identifier Type: -
Identifier Source: org_study_id
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