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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyalobarrier | Experimental | ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml*10ml/syringe and 5cm-cannula |
|
| Guardix-SG | Active Comparator | Poloxamer/sodium alginate mixture 6g/syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyalobarrier | Device |
| ||
| Guardix-SG |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of normal esophageal transit in marshmallow esophagography | 6 Weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion severity using VAS | Baseline and 1, 6 and 12 weeks | |
| Swallow impairment | Baseline and 1, 6 and 12 weeks | |
| Voice impairment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | South Korea | ||||
| Korea University Anam Hospital |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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|
| Baseline and 1, 6 and 12 weeks |
| voice behavior using Voice Range Profile (VRP) assessment | Baseline and 1, 6 and 12 weeks |
| Injury of recurrent laryngeal nerve | Baseline and 1, 6 and 12 weeks |
| Postoperative Sore Throat within 24hours after thyroidectomy | Pre- and Post (0, 24h)-opreation |
| Adverse Events | during 12 weeks after investigational device use |
| Seoul |
| South Korea |
| Korea University Guro Hospital | Seoul | South Korea |