A Phase 3 interventional study of Hyalobarrier and Guardix-SG in Thyroid Disease, sponsored by Green Cross Corporation. Completed at 3 sites in Korea, Republic of. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2014-02-28.
Sponsored by Green Cross Corporation · Phase 3, Interventional, and Treatment
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.
967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.
This study's enrollment of 198 is above the median of 60 across 544 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Green Cross Corporation is the lead sponsor of 61 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml\*10ml/syringe and 5cm-cannula
Device: Hyalobarrier
Poloxamer/sodium alginate mixture 6g/syringe
Device: Guardix-SG
The percentage of normal esophageal transit in marshmallow esophagography
Time frame: 6 Weeks after intervention
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
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Green Cross Corporation