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

Primary Purpose

Thyroid Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hyalobarrier
Guardix-SG
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Disease focused on measuring Thyroid disease, Hyalobarrier, Thyroidectomy, anti-adhesive effect

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Konkuk University Medical Center
  • Korea University Anam Hospital
  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyalobarrier

Guardix-SG

Arm Description

ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml*10ml/syringe and 5cm-cannula

Poloxamer/sodium alginate mixture 6g/syringe

Outcomes

Primary Outcome Measures

The percentage of normal esophageal transit in marshmallow esophagography

Secondary Outcome Measures

Adhesion severity using VAS
Swallow impairment
Voice impairment
voice behavior using Voice Range Profile (VRP) assessment
Injury of recurrent laryngeal nerve
Postoperative Sore Throat within 24hours after thyroidectomy
Adverse Events

Full Information

First Posted
September 26, 2012
Last Updated
February 27, 2014
Sponsor
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01696305
Brief Title
Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy
Official Title
Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Disease
Keywords
Thyroid disease, Hyalobarrier, Thyroidectomy, anti-adhesive effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyalobarrier
Arm Type
Experimental
Arm Description
ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml*10ml/syringe and 5cm-cannula
Arm Title
Guardix-SG
Arm Type
Active Comparator
Arm Description
Poloxamer/sodium alginate mixture 6g/syringe
Intervention Type
Device
Intervention Name(s)
Hyalobarrier
Intervention Type
Device
Intervention Name(s)
Guardix-SG
Primary Outcome Measure Information:
Title
The percentage of normal esophageal transit in marshmallow esophagography
Time Frame
6 Weeks after intervention
Secondary Outcome Measure Information:
Title
Adhesion severity using VAS
Time Frame
Baseline and 1, 6 and 12 weeks
Title
Swallow impairment
Time Frame
Baseline and 1, 6 and 12 weeks
Title
Voice impairment
Time Frame
Baseline and 1, 6 and 12 weeks
Title
voice behavior using Voice Range Profile (VRP) assessment
Time Frame
Baseline and 1, 6 and 12 weeks
Title
Injury of recurrent laryngeal nerve
Time Frame
Baseline and 1, 6 and 12 weeks
Title
Postoperative Sore Throat within 24hours after thyroidectomy
Time Frame
Pre- and Post (0, 24h)-opreation
Title
Adverse Events
Time Frame
during 12 weeks after investigational device use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoon Yub Kim, M.D., Ph.D.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae-Bok Lee, M.D., Ph.D.
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyoung Sik Park, M.D., Ph.D.
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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