Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy

Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy

This study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid surgery).

An eligible patient will be randomized and allocated to either the test group (Hyalobarrier) or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for 12weeks.

During the study, both the patients and the observer for the primary and secondary efficacy evaluation will be masked.

Non-inferiority of the test device (Hyalobarrier) compared to the reference device (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal esophageal transit.

Study Overview

• Status: Completed
• Conditions: Thyroid Disease
• Intervention / Treatment: Device: Hyalobarrier; Device: Guardix-SG

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female between 18 and 79 years of age
• Patients diagnosed with thyroid disease who will undergo total thyroidectomy
• Naive patients to thyroid surgery
• Given written informed consent
• Childbearing potential female patients who give the consent for contraception during the study

Exclusion Criteria:

• Pregnant or breast-feeding female patients
• Abnormal coagulation panel test
• Clinically abnormal laboratory values
• Inappropriate general health conditions
• Past or current medication history for hyperthyroidism
• Medication with aspirin (or anti-platelet) before surgery
• Current medication with anticoagulants
• Inoperable (thyroidectomy) concurrent diseases
• Concurrent diseases/conditions which will be unable to evaluate the primary and secondary outcomes
• Participating in other interventional clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyalobarrier; ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml*10ml/syringe and 5cm-cannula	Device: Hyalobarrier
Active Comparator: Guardix-SG; Poloxamer/sodium alginate mixture 6g/syringe	Device: Guardix-SG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of normal esophageal transit in marshmallow esophagography	6 Weeks after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Adhesion severity using VAS	Baseline and 1, 6 and 12 weeks
Swallow impairment	Baseline and 1, 6 and 12 weeks
Voice impairment	Baseline and 1, 6 and 12 weeks
voice behavior using Voice Range Profile (VRP) assessment	Baseline and 1, 6 and 12 weeks
Injury of recurrent laryngeal nerve	Baseline and 1, 6 and 12 weeks
Postoperative Sore Throat within 24hours after thyroidectomy	Pre- and Post (0, 24h)-opreation
Adverse Events	during 12 weeks after investigational device use

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: Hoon Yub Kim, M.D., Ph.D., Korea University Anam Hospital; Principal Investigator: Jae-Bok Lee, M.D., Ph.D., Korea University Guro Hospital; Principal Investigator: Kyoung Sik Park, M.D., Ph.D., Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Thyroidectomy; Thyroid disease; Hyalobarrier; anti-adhesive effect
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: Hyalobarrier_P3