NCT04185922 - 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)

Fossati N, Willemse PM, Van den Broeck T, van den Bergh RCN, Yuan CY, Briers E, Bellmunt J, Bolla M, Cornford P, De Santis M, MacPepple E, Henry AM, Mason MD, Matveev VB, van der Poel HG, van der Kwast TH, Rouvière O, Schoots IG, Wiegel T, Lam TB, Mottet N, Joniau S
The Benefits and Harms of Different Extents of Lymph Node Dissection During Radical Prostatectomy for Prostate Cancer: A Systematic Review. Eur Urol. 2017 Jul;72(1):84-109. doi: 10.1016/j.eururo.2016.12.003. Epub 2017 Jan 24. Review.
Gilbert DR, Angell J, Abaza R
Evaluation of Absorbable Hemostatic Powder for Prevention of Lymphoceles Following Robotic Prostatectomy With Lymphadenectomy. Urology. 2016 Dec;98:75-80. doi: 10.1016/j.urology.2016.06.071. Epub 2016 Sep 1.
Lewis KM, Kuntze CE, Gulle H
Control of bleeding in surgical procedures: critical appraisal of HEMOPATCH (Sealing Hemostat). Med Devices (Auckl). 2015 Dec 22;9:1-10. doi: 10.2147/MDER.S90591. eCollection 2016. Review.
Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouvière O, Schoots IG, Wiegel T, Cornford P
EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.
Simonato A, Varca V, Esposito M, Venzano F, Carmignani G
The use of a surgical patch in the prevention of lymphoceles after extraperitoneal pelvic lymphadenectomy for prostate cancer: a randomized prospective pilot study. J Urol. 2009 Nov;182(5):2285-90. doi: 10.1016/j.juro.2009.07.033. Epub 2009 Sep 16.

Hemopatch to Prevent Lymphatic Leak After Robotic Prostatectomy and Pelvic Lymph Node Dissection: a Randomized Controlled Trial

Details for clinical trial NCT04185922

Clinical trial NCT04185922 - References