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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01696305
First received: September 26, 2012
Last updated: February 27, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adhesion severity using VAS [ Time Frame: Baseline and 1, 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Swallow impairment [ Time Frame: Baseline and 1, 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Voice impairment [ Time Frame: Baseline and 1, 6 and 12 weeks ] [ Designated as safety issue: No ]
  • voice behavior using Voice Range Profile (VRP) assessment [ Time Frame: Baseline and 1, 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Injury of recurrent laryngeal nerve [ Time Frame: Baseline and 1, 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Postoperative Sore Throat within 24hours after thyroidectomy [ Time Frame: Pre- and Post (0, 24h)-opreation ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: during 12 weeks after investigational device use ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696305

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

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01696305     History of Changes
Other Study ID Numbers: Hyalobarrier_P3
Study First Received: September 26, 2012
Last Updated: February 27, 2014
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014