Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01696305
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.
Study:
NCT01696305
Study Brief:
Protocol Section:
NCT01696305