NCT02122341 - 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)

Chow GK, Patterson DE, Blute ML, Segura JW
Ureteroscopy: effect of technology and technique on clinical practice. J Urol. 2003 Jul;170(1):99-102.
Hendrikx AJ, Strijbos WE, de Knijff DW, Kums JJ, Doesburg WH, Lemmens WA
Treatment for extended-mid and distal ureteral stones: SWL or ureteroscopy? Results of a multicenter study. J Endourol. 1999 Dec;13(10):727-33.
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use
ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50.
Knispel HH, Klän R, Heicappell R, Miller K
Pneumatic lithotripsy applied through deflected working channel of miniureteroscope: results in 143 patients. J Endourol. 1998 Dec;12(6):513-5.
Pardalidis NP, Kosmaoglou EV, Kapotis CG
Endoscopy vs. extracorporeal shockwave lithotripsy in the treatment of distal ureteral stones: ten years' experience. J Endourol. 1999 Apr;13(3):161-4.
Rane A, Bradoo A, Rao P, Shivde S, Elhilali M, Anidjar M, Pace K, D'A Honey JR
The use of a novel reverse thermosensitive polymer to prevent ureteral stone retropulsion during intracorporeal lithotripsy: a randomized, controlled trial. J Urol. 2010 Apr;183(4):1417-21. doi: 10.1016/j.juro.2009.12.023. Epub 2010 Feb 20.
Robert M, Bennani A, Guiter J, Avérous M, Grasset D
Treatment of 150 ureteric calculi with the Lithoclast. Eur Urol. 1994;26(3):212-5.
Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn RI, Lingeman JE, Macaluso JN Jr
Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol. 1997 Nov;158(5):1915-21.

Post FDA-Approval Clinical Evaluation of BackStopTM in Patients Undergoing Ureteroscopic Lithotripsy: A Prospective, Randomized Clinical Trial

Details for clinical trial NCT02122341

Clinical trial NCT02122341 - References