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

Study Overview
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Brief Summary
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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.

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

Conditions
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Thyroid Disease

Intervention / Treatment
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* Device: Hyalobarrier
* Device: Guardix-SG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyalobarrier<br>ACP200 (Auto-crosslinked polysaccharide:inner ester of hyaluronic acid) 30mg/ml*10ml/syringe and 5cm-cannula | Device: Hyalobarrier<br> <br> |
| Active Comparator: Guardix-SG<br>Poloxamer/sodium alginate mixture 6g/syringe | Device: Guardix-SG<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of normal esophageal transit in marshmallow esophagography |  | 6 Weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyalobarrier, Thyroidectomy, anti-adhesive effect, Thyroid disease