NCT02792322 - 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)

Engelhardt M, Folkers W, Brenke C, Scholz M, Harders A, Fidorra H, Schmieder K
Neurosurgical operations with the patient in sitting position: analysis of risk factors using transcranial Doppler sonography. Br J Anaesth. 2006 Apr;96(4):467-72. doi: 10.1093/bja/ael015. Epub 2006 Feb 7.
Matjasko J, Petrozza P, Cohen M, Steinberg P
Anesthesia and surgery in the seated position: analysis of 554 cases. Neurosurgery. 1985 Nov;17(5):695-702. doi: 10.1227/00006123-198511000-00001.
Moore EJ, Olsen KD, Martin EJ
Concurrent neck dissection and transoral robotic surgery. Laryngoscope. 2011 Mar;121(3):541-4. doi: 10.1002/lary.21435. Epub 2011 Jan 4.
Moore EJ, Olsen SM, Laborde RR, Garcia JJ, Walsh FJ, Price DL, Janus JR, Kasperbauer JL, Olsen KD
Long-term functional and oncologic results of transoral robotic surgery for oropharyngeal squamous cell carcinoma. Mayo Clin Proc. 2012 Mar;87(3):219-25. doi: 10.1016/j.mayocp.2011.10.007.
Van Abel KM, Moore EJ
The rise of transoral robotic surgery in the head and neck: emerging applications. Expert Rev Anticancer Ther. 2012 Mar;12(3):373-80. doi: 10.1586/era.12.7.
Weinstein GS, O'Malley BW Jr, Desai SC, Quon H
Transoral robotic surgery: does the ends justify the means? Curr Opin Otolaryngol Head Neck Surg. 2009 Apr;17(2):126-31. doi: 10.1097/MOO.0b013e32832924f5.
Weinstein GS, O'Malley BW Jr, Magnuson JS, Carroll WR, Olsen KD, Daio L, Moore EJ, Holsinger FC
Transoral robotic surgery: a multicenter study to assess feasibility, safety, and surgical margins. Laryngoscope. 2012 Aug;122(8):1701-7. doi: 10.1002/lary.23294. Epub 2012 Jul 2.

A Pilot Study Assessing Robotic Surgery in the Seated or Supine Position for Benign and Malignant Lesions of the Head and Neck Using the da Vinci Robotic Surgical Systems and Modified Transoral Instrumentation

Details for clinical trial NCT02792322

Clinical trial NCT02792322 - References