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

Phase 3

• Conditions: Patients With Thyroidectomy (Scheduled)

• Registration Number: NCT02940210
• Lead Sponsor: CGBio Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Status Verified: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Last Update Submitted: 2016-10-19
• Study First Posted: 2016-10-20
• Last Update Posted: 2016-10-20
• Primary Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adhesion incidence rate following 8 weeks	8 weeks

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Su won, Gyeonggi-do, Korea, Republic of

Ajou University Hospital

🇰🇷Su won, Gyeonggi-do, Korea, Republic of

Ha Eun Lee

Contact

+82-31-219-4536