Ignite Creation Date:
2024-05-06 @ 12:57 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01696305
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2012-09-26
Brief Title:
Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Prospective Randomized Double Blind Multicenter Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Heshe 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 outcomethe percentage of normal esophageal transit
An eligible patient will be randomized and allocated to either the test group Hyalobarrier or active-comparator group Guardix-SG Heshe 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 outcomethe percentage of normal esophageal transit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None