NCT00661024 - 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)

Barczynski M, Konturek A, Cichon S
[Value of the intraoperative neuromonitoring in surgery for thyroid cancer in identification and prognosis of function of the recurrent laryngeal nerves]. Endokrynol Pol. 2006 Jul-Aug;57(4):343-6. Polish.
Dralle H, Sekulla C, Lorenz K, Brauckhoff M, Machens A; German IONM Study Group
Intraoperative monitoring of the recurrent laryngeal nerve in thyroid surgery. World J Surg. 2008 Jul;32(7):1358-66. doi: 10.1007/s00268-008-9483-2. Review.
Snyder SK, Hendricks JC
Intraoperative neurophysiology testing of the recurrent laryngeal nerve: plaudits and pitfalls. Surgery. 2005 Dec;138(6):1183-91; discussion 1191-2.
Thomusch O, Sekulla C, Machens A, Neumann HJ, Timmermann W, Dralle H
Validity of intra-operative neuromonitoring signals in thyroid surgery. Langenbecks Arch Surg. 2004 Nov;389(6):499-503. Epub 2004 Jan 13.
Tomoda C, Hirokawa Y, Uruno T, Takamura Y, Ito Y, Miya A, Kobayashi K, Matsuzuka F, Kuma K, Miyauchi A
Sensitivity and specificity of intraoperative recurrent laryngeal nerve stimulation test for predicting vocal cord palsy after thyroid surgery. World J Surg. 2006 Jul;30(7):1230-3.

Randomized Clinical Trial Evaluating Visualization Versus Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerves in Thyroid Surgery

Clinical trial NCT00661024 - References