NCT03317990 - 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)

Beyer B, Schlomm T, Tennstedt P, Boehm K, Adam M, Schiffmann J, Sauter G, Wittmer C, Steuber T, Graefen M, Huland H, Haese A
A feasible and time-efficient adaptation of NeuroSAFE for da Vinci robot-assisted radical prostatectomy. Eur Urol. 2014 Jul;66(1)
Vasdev N, Agarwal S, Rai BP, Soosainathan A, Shaw G, Chang S, Prasad V, Mohan-S G, Adshead JM
Intraoperative Frozen Section of the Prostate Reduces the Risk of Positive Margin Whilst Ensuring Nerve Sparing in Patients with Intermediate and High-Risk Prostate Cancer Undergoing Robotic Radical Prostatectomy: First Reported UK Series. Curr Urol. 2016 May;9(2):93-103. doi: 10.1159/000442860. Epub 2016 May 20.

A Single Blinded, IDEAL Stage 3, Multi-Centre, Randomised Controlled Trial to Assess NeuroSAFE Robotic Assisted Radical Prostatectomy (RARP) vs Standard Robotic Assisted Radical Prostatectomy (RARP) in Men With Prostate Cancer

Details for clinical trial NCT03317990

Clinical trial NCT03317990 - References