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 range20 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. The subject (male and female) aged between 20 \~ 65.
âś“. The subject planned a first thyroidectomy for thyroid disease.
âś“. The subject did not have medical history of esophagus-related disease
âś“. The subject was suitable for local anesthesia or general anesthesia (Respiration and Intravenous anesthesia)
âś“. 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.
âś“. The subject has been informed of the nature of the study (objective, methodology, efficacy, etc.) and signed written informed consent.
âś“. The subject has been informed the efficacy and risk of anesthesia related to the surgery, procedures and examination, etc. and singed written informed consent.
âś“. The subject who agrees to comply with permitted contraception during the study (example of permitted contraception: using condom and infertility surgery, etc.)
Exclusion criteria
âś•. The subject had general or local infection.
âś•. The subject was diagnosed with liver and/or kidney and coagulation abnormalities.
âś•. The subject took the prohibited concomitant medication.
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 had suppressed immunity or autoimmune disease
âś•. The subject had hypersensitivity to the investigational devices.
âś•. The subject was pregnant of a nursing mother or those who plan pregnancy during the study.
âś•. The subject had serious disease that may affect to the study justified by Investigators (example: heart failure, kidney failure, pancreatitis, and diabetes, etc.)
âś•. 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.