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

October 19, 2016 updated by: CGBio Inc.

A Randomized, Single-blind, Multi-center, Phase III Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Su won, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Ha Eun Lee
          • Phone Number: +82-31-219-4536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mediclore®
adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy
Device: Mediclore® (adhesion barrier)
NO_INTERVENTION: No treatment
No treatment, standard treatment for thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adhesion incidence rate following 8 weeks
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CGBio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (ESTIMATE)

October 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 20, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG-AHS004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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