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

Primary Purpose

Patients With Thyroidectomy (Scheduled)

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mediclore® (adhesion barrier)
Sponsored by
CGBio Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patients With Thyroidectomy (Scheduled)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mediclore®

No treatment

Arm Description

adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy

No treatment, standard treatment for thyroidectomy

Outcomes

Primary Outcome Measures

Adhesion incidence rate following 8 weeks

Secondary Outcome Measures

Full Information

First Posted
October 19, 2016
Last Updated
October 19, 2016
Sponsor
CGBio Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02940210
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CGBio Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Thyroidectomy (Scheduled)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mediclore®
Arm Type
Experimental
Arm Description
adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment, standard treatment for thyroidectomy
Intervention Type
Device
Intervention Name(s)
Mediclore® (adhesion barrier)
Primary Outcome Measure Information:
Title
Adhesion incidence rate following 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan Huh
Phone
+82-2-550-8106
Email
whuh408@daewoong.co.kr
Facility Information:
Facility Name
Ajou University Hospital
City
Su won
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ha Eun Lee
Phone
+82-31-219-4536

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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