Anti-adhesive Effect and Safety of MEDICURTAIN Applied to Undergoing Thyroid Surgery (Pivotal Study) (NCT05058027) | Clinical Trial Compass
CompletedNot Applicable
Anti-adhesive Effect and Safety of MEDICURTAIN Applied to Undergoing Thyroid Surgery (Pivotal Study)
South Korea170 participantsStarted 2013-07-04
Plain-language summary
This study was designed to demonstrate the non-inferiority of MEDICURTAIN® (investigational device) compared to commercially available GUARDIX-SG® (control device) in treatment of subject who underwent total thyroidectomy for prevention of adhesion formation at 6 weeks after the surgery.
Who can participate
Age range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject (male and female) aged between 20 \~ 65.
. The subject planned a first thyroidectomy for thyroid disease.
. The subject did not have medical history of esophagus-related disease
. The subject was suitable for local anesthesia or general anesthesia (Respiration and Intravenous anesthesia)
. The subject who could communicate with the investigators fluently, understands the purpose of clinical trial and the risk of participation in the clinical trial, and was willing to comply with guideline for clinical trial.
. The subject has been informed of the nature of the study (objective, methodology, efficacy, etc.) and signed written informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of abnormal findings of esophageal motility evaluated by the independent third evaluator using marshmallow esophagography obtained at 6 weeks after administration of investigational device.
. The subject has been informed the efficacy and risk of anesthesia related to the surgery, procedures and examination, etc. and singed written informed consent.
. The subject who agrees to comply with permitted contraception during the study (example of permitted contraception: using condom and infertility surgery, etc.)
Exclusion criteria
. The subject had general or local infection.
. The subject was diagnosed with liver and/or kidney and coagulation abnormalities.
. The subject took the prohibited concomitant medication.
. The subject had suppressed immunity or autoimmune disease
. The subject had hypersensitivity to the investigational devices.
. The subject was pregnant of a nursing mother or those who plan pregnancy during the study.
. The subject had serious disease that may affect to the study justified by Investigators (example: heart failure, kidney failure, pancreatitis, and diabetes, etc.)
. The subjects participate in another investigational study after enrollment of this study or subject previously participated in another investigational study within last 3 months before participating in this study.