NCT02554422 - Clinical Trial References

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.

Citation(s)

Gyo K, Sato H, Yumoto E, Yanagihara N
Assessment of stapes mobility by use of a newly developed piezoelectric ceramic device. A preliminary experiment in dogs. Ann Otol Rhinol Laryngol. 2000 May;109(5):473-7.
Hato N, Kohno H, Okada M, Hakuba N, Gyo K, Iwakura T, Tateno M
A new tool for testing ossicular mobility during middle ear surgery: preliminary report of four cases. Otol Neurotol. 2006 Aug;27(5):592-5.
Hato N, Stenfelt S, Goode RL
Three-dimensional stapes footplate motion in human temporal bones. Audiol Neurootol. 2003 May-Jun;8(3):140-52.
Huber A, Linder T, Ferrazzini M, Schmid S, Dillier N, Stoeckli S, Fisch U
Intraoperative assessment of stapes movement. Ann Otol Rhinol Laryngol. 2001 Jan;110(1):31-5.
Koike T, Murakoshi M, Hamanishi S, Yuasa Y, Yuasa R, Kobayashi T, Wada H
An apparatus for diagnosis of ossicular chain mobility in humans. Int J Audiol. 2006 Feb;45(2):121-8.
Lau HH, Michler H, Zollner F
Versuch einer technischen Verbesserung der Schallsonde. Acta Otolaryngol 1963;56:421-7
Seidman MD, Standring RT, Ahsan S, Marzo S, Shohet J, Lumley C, Verzal K
Normative data of incus and stapes displacement during middle ear surgery using laser Doppler vibrometry. Otol Neurotol. 2013 Dec;34(9):1719-24. doi: 10.1097/MAO.0b013e3182976528.
Shea MC Jr
Postinflammatory osteogenic fixation of the stapes. Laryngoscope. 1977 Dec;87(12):2056-65.
Zahnert T, Hüttenbrink KB, Bornitz M, Hofmann G
[Intraoperative measurement of stapes mobility using a hand-guided electromagnetic probe]. Laryngorhinootologie. 2001 Feb;80(2):71-7. German.
Zöllner F
Die bisherigen Ergebnisse der Schallsondenunersuchungen. Arch Ohren-, Nasen- und Kehlkopfheilkunde 1951;159:358-364

Messung Der Beweglichkeit Der Gehörknöchelchenkette während Einer Ohroperation. ("Objective Measurements of Ossicular Chain Mobility Using a Palpating Instrument Intraoperatively")

Details for clinical trial NCT02554422

Clinical trial NCT02554422 - References