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

Green Cross Corporation

Status and phase: Completed; Phase 3

Conditions: Thyroid Disease

Treatments: Device: Guardix-SG; Device: Hyalobarrier

Study type: Interventional

Funder types: Industry

Identifiers

NCT01696305

Hyalobarrier_P3

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

Hyalobarrier

Experimental group

Description:

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

Treatment:

Device: Hyalobarrier

Guardix-SG

Active Comparator group

Description:

Poloxamer/sodium alginate mixture 6g/syringe

Treatment:

Device: Guardix-SG