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

Thyroid Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696305
• Other study ID #: Hyalobarrier_P3
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2012
• Last updated: February 27, 2014
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Disease
• Thyroid Diseases

Intervention

Device:
• Hyalobarrier

• Guardix-SG

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of normal esophageal transit in marshmallow esophagography		6 Weeks after intervention	No
Secondary	Adhesion severity using VAS		Baseline and 1, 6 and 12 weeks	No
Secondary	Swallow impairment		Baseline and 1, 6 and 12 weeks	No
Secondary	Voice impairment		Baseline and 1, 6 and 12 weeks	No
Secondary	voice behavior using Voice Range Profile (VRP) assessment		Baseline and 1, 6 and 12 weeks	No
Secondary	Injury of recurrent laryngeal nerve		Baseline and 1, 6 and 12 weeks	No
Secondary	Postoperative Sore Throat within 24hours after thyroidectomy		Pre- and Post (0, 24h)-opreation	No
Secondary	Adverse Events		during 12 weeks after investigational device use	Yes