A Multicenter, Randomized, Active-controlled, Exploratory Clinical Trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty for patients with chronic Eustachian tube dysfunction

Mega Medical0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年1月6日

研究概览

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•* Subjects must meet all the following criteria.
•(1) Male or female over the age of 19
•(2) Chronic Eustachian tube dysfunction patients with one or more of the criteria below
•a) Those who have three or more of the following symptoms for 12 months or longer; ear pain, ear pressure, tinnitus, cracking or popping in ears, muffled hearing, feeling that ears are clogged.
•b) Those with otitis media with effusion whose symptoms persist even after medication.
•c) Those with adhesive otitis media whose symptoms persist even after medication.
•(3) Patients who voluntarily agreed in writing to participate in this clinical trial.

•* Subjects who meet any of the following criteria cannot participate in this study.
•(1) Those with proved dehiscence of internal carotid artery near the Eustachian tube in computed tomography (CT) scan.
•(2) Patients with patulous Eustachian tube.
•(3) Patients with tympanic membrane perforation or ventilation tube insertion state.
•(4) Patients who have Meniere’s disease or chronic sinusitis.
•(5) Those who have anatomy that are difficult for transnasal-approach to Eustachian tube.
•(6) Those who have history of major head or neck surgery within 4 months.
•(7) Patients with active chronic or acute otitis media.
•(8) Pregnant, nursing, or childbearing-age women that have plan to get pregnant during the study period.
•(9) Those with clinically significant liver disease (ALT or AST results are more than 2.5~3 times the normal upper limit in screening test).
•(10) Those with clinically significant kidney disease (serum Creatinine result is more than 2.0 mg/dL in screening test) or with hemodialysis.
•(11) Those who have history of malignancy including leukemia and lymphoma within past 5 years.
•(12) Those who have experience of other clinical trial within past 4 weeks before this study.
•(13) In case that researcher judged that participation in this clinical trial is not appropriate.

发起方

Mega Medical