Thyroid Disease
Conditions
Keywords
Thyroid disease, Hyalobarrier, Thyroidectomy, anti-adhesive effect
Brief summary
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.
Interventions
DEVICEHyalobarrier
DEVICEGuardix-SG
Sponsors
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of normal esophageal transit in marshmallow esophagography | 6 Weeks after intervention |
Secondary
| Measure | 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 |
| Adverse Events | during 12 weeks after investigational device use |
| 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 |
| voice behavior using Voice Range Profile (VRP) assessment | Baseline and 1, 6 and 12 weeks |
Countries
South Korea
Outcome results
None listed