Prospective, Randomized, Double Blind, Multicenter Study for Hyalobarrier ® to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG® After Thyroidectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 3
- 主要终点
- The percentage of normal esophageal transit in marshmallow esophagography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The percentage of normal esophageal transit in marshmallow esophagography
时间窗: 6 Weeks after intervention
次要结局
- 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)
- Adhesion severity using VAS(Baseline and 1, 6 and 12 weeks)
- Swallow impairment(Baseline and 1, 6 and 12 weeks)