None listed
Conditions
Interventions
Medical Device : Eligible patient according to inclusion/exclusion criteria is enrolled and assigned by randomization code. (3 digit), On operaiton day, investigator oeprates total thyroidectomy and t
Sponsors
L&C BIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) patient who gives written informed consent spontaneously (2) between 20 and 70 years of age (3) patient who can participate the clinical trial (4) patient diagnosed with thyroid disease who will undergo total thyroidectomy (5) Naive patients to thyroid surgery (6) During screening test, normal in liver and kidney condition (7) Childbearing potential female patients who give the consent for contraception during the study
Exclusion criteria
Exclusion criteria: (1)Pregnant or breast-feeding female patients (2) Severe liver or kidney disease (3) Lymphatid fluid or blood coagulation disease patient or coagulation medication patient (4) current medication of Anti-diabetics (5) Auto immune disease of immune suppressed patient (6) severe health conditions (7) Accompanied operation expected patient (8) current anti-cancer treatment (9) other anti-adhesion treatment (10) inappropriate patient by investigator's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Swallowing function test is evaluated using Marshmallow esophagography. | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical symptoms evaluation through questionaire;Safety evaluation : all of adverse events collected and evaluated | — |
Countries
Korea, Republic of
Contacts
Public ContactKeeHyun Nam
Yonsei University Health System, Severance Hospital
Outcome results
None listed