Glue Ear — Balloon Dilation of the Eustachian Tube in Children
Citation(s)
Jenckel F, Kappo N, Gliese A, Loewenthal M, Lörincz BB, Knecht R, Dalchow CV Endonasal dilatation of the Eustachian tube (EET) in children: feasibility and the role of tubomanometry (Estève) in outcomes measurement. Eur Arch Otorhinolaryngol. 2015 Dec;272(12):3677-83. doi: 10.1007/s00405-014-3443-2. Epub 2014 Dec 19.
Maier S, Tisch M, Maier H [Balloon dilation of the Eustachian tube in pediatric chronic obstructive Eustachian tube dysfunction patients]. HNO. 2015 Oct;63(10):686-8, 690-4, 696-7. doi: 10.1007/s00106-015-0050-5. German.
Popova D, Varbanova S, Popov TM Comparison between myringotomy and tympanostomy tubes in combination with adenoidectomy in 3-7-year-old children with otitis media with effusion. Int J Pediatr Otorhinolaryngol. 2010 Jul;74(7):777-80. doi: 10.1016/j.ijporl.2010.03.054.
Tisch M, Maier S, Hecht P, Maier H [Bilateral Eustachian tube dilation in infants: an alternative treatment for persistent middle ear functional dysfunction]. HNO. 2013 Jun;61(6):492-3. doi: 10.1007/s00106-013-2713-4. German.
Van Roeyen S, Van de Heyning P, Van Rompaey V Delayed-Start Study Design for Balloon Dilation of the Eustachian Tube: Alternative for a Randomized Controlled Trial. Front Surg. 2017 Feb 20;4:10. doi: 10.3389/fsurg.2017.00010. eCollection 2017.
Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
