NCT01581905 - 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)

Pasic RP, Rizzo JA, Fang H, Ross S, Moore M, Gunnarsson C
Comparing robot-assisted with conventional laparoscopic hysterectomy: impact on cost and clinical outcomes. J Minim Invasive Gynecol. 2010 Nov-Dec;17(6):730-8. doi: 10.1016/j.jmig.2010.06.009.
Payne TN, Dauterive FR
A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008 May-Jun;15(3):286-91. doi: 10.1016/j.jmig.2008.01.008.
Sarlos D, Kots L, Stevanovic N, Schaer G
Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012.
Sarlos D, Kots LA
Robotic versus laparoscopic hysterectomy: a review of recent comparative studies. Curr Opin Obstet Gynecol. 2011 Aug;23(4):283-8. doi: 10.1097/GCO.0b013e328348a26e. Review.
Shashoua AR, Gill D, Locher SR
Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009 Jul-Sep;13(3):364-9.

A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

Details for clinical trial NCT01581905

Clinical trial NCT01581905 - References