Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy

NCT ID: NCT02909270

Last Updated: 2016-09-21

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

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Brief Summary

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A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy and safety of adhesion barrier Mediclore versus no treatment in patients with total thyroidectomy

Detailed Description

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Conditions

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Patients With Thyroidecomy (Scheduled)

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 thyroid gland following thyroidectomy

Group Type EXPERIMENTAL

Mediclore

Intervention Type DEVICE

to apply mediclore fully around thyroid gland

No treatment

No treatment, standard treatment for thyroidectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mediclore

to apply mediclore fully around thyroid gland

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Male or female at least 20 years of age
* Patients without clinically significant lab
* Patients scheduled for thyroidectomy

Exclusion Criteria

* Another clinical trials within 1 month
* 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 hypertentsion, 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Wan Huh

Role: CONTACT

+82-2-550-8106 ext. 8106

Facility Contacts

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Ha Eun Lee

Role: primary

+8231-219-4536

Other Identifiers

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CG-AHS004

Identifier Type: -

Identifier Source: org_study_id

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