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