Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pi… (NCT05049434) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pivotal Study)
South Korea77 participantsStarted 2014-03-03
Plain-language summary
This clinical trial is to prove that the treatment group of Medicurtain® is non-inferior to the treatment group of Guardix-sol®, test equipment on adhesion after endoscopic sinus surgery, upon the aspects of adhesion prevention efficacy and safety.
Who can participate
Age range19 Years – 69 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“. Patients at the age of between 19 and 69
âś“. Patients scheduled for surgery with chronic or relapsed sinusitis not responding to drug therapy (Verification to be made based on past clinical history, physical examination and radiography)
âś“. Patients with the discrepancy of Lund-MacKay CT scan scores on bilateral sinusitis less than 3
âś“. Patients who signed written consent after listening to the objective, method and effects of clinical trial
âś“. Patients available during the period of clinical trial
Exclusion criteria
âś•. Patients with sinusitis on only one nasal cavity
âś•. Patients with massive sinonasal polyposis
âś•. Patients with one or both middle turbinate removed, in addition to a history of endoscopic surgery or polyp operation
âś•. Patients with ongoing drug administration for asthma
âś•. Patients with immune disorders which may potentially hinder healing of the wounds including acquired immunodeficiency syndrome, cystofibroma, immotile cilia syndrome, neutropenia and immune globulin deficiency
âś•. Patients with immunosuppression or autoimmune disease
âś•. Patients with hypersensitivity reaction to Poloxamer and Hyaluronic acid
What they're measuring
1
Difference between effective ratio (Pt=P00+P01) of medical device for clinical trial and effective ratio (Pc=P00+P10) of medical device for control test evaluated by independent assessor at the 4th week following the application of medical device