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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696305
First Posted: October 1, 2012
Last Update Posted: February 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Green Cross Corporation
  Purpose

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.


Condition Intervention Phase
Thyroid Disease Device: Hyalobarrier Device: Guardix-SG Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • The percentage of normal esophageal transit in marshmallow esophagography [ Time Frame: 6 Weeks after intervention ]

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

Enrollment: 198
Study Start Date: December 2012
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696305


Locations
Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
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
  More Information

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01696305     History of Changes
Other Study ID Numbers: Hyalobarrier_P3
First Submitted: September 26, 2012
First Posted: October 1, 2012
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Green Cross Corporation:
Thyroid disease
Hyalobarrier
Thyroidectomy
anti-adhesive effect

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases