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A multi-center, randomized, parallel, assessor-blind, non-inferiority, prospective clinical trial to evaluate the efficacy and safety of PEO GUARD in patients after total Thyroidectomy

A multi-center, randomized, parallel, assessor-blind, non-inferiority, prospective clinical trial to evaluate the efficacy and safety of PEO GUARD in patients after total Thyroidectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007896
Enrollment
176
Registered
2022-11-11
Start date
2019-05-08
Completion date
Unknown
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Among the test subjects, those who voluntarily consent in writing to participate in the clinical trial and then evaluate the selection/exclusion criteria and are found to be suitable

Sponsors

Pusan National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) A person who signs or seals the written consent of the test subject to participation in the study; 2) Men or women over 20 years of age who are eligible to participate during the clinical trial 3) A person who has no clinically significant abnormal findings in a preoperative laboratory examination 4) A person who is scheduled to operate on a thyroidectomy

Exclusion criteria

Exclusion criteria: 1) Patients who have participated in other clinical trials and received medication or medical treatment within one month prior to enrollment in this clinical trial 2) A person who has a history of surgery in the same area 3) If you receive anticoagulant therapy or systemic steroid therapy within one week of the treatment date 4) If you have an immunosuppressive or autoimmune disease 5) If you are allergic to substances used in clinical trials 6) Those who have infections in the whole body and surgical areas 7) Patients with serious conditions (e.g., heart failure, kidney failure, liver failure, uncontrolled blood pressure, diabetes, blood clotting disorder, etc.) that the tester believes may affect surgery 8) A person who takes (or is scheduled to) a combination of prohibited substances 9) Alcohol or drug addiction, psychotic 10) Pregnant women, lactating women, and patients who are planning to conceive during this clinical trial or have self-reproducing ability to disagree with contraception cannot use recognized contraception during the trial period (accredited contraception refers to hepatic wall infertility surgery, oral contraception, etc 11) A person who has a history of esophageal-related diseases 12) Those who are expected to be keloids in the wound healing process 13) Other persons who are deemed difficult to perform this clinical trial when judged by the tester

Design outcomes

Primary

MeasureTime frame
Marshmallow sikttongjoyeongsul the normal rate of esophageal motor skills through.;Score of esophageal motility through esophageal angiography of marshmallow;Changes in clinical symptoms through a questionnaire (Voice, Swallowing Score) completed by the test subject at 2 weeks and 8 weeks after surgery compared to preoperative surgery

Secondary

MeasureTime frame
Voice Disorder Questionnaire;Swallowing Disorder Questionnaire

Countries

Korea, Republic of

Contacts

Public ContactByung Joo Lee

Pusan National University Hospital

voiceleebj@gmail.com+82-51-240-7328

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026