NCT04829461 - 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)

Gee JR, Waterman BJ, Jarrard DF, Hedican SP, Bruskewitz RC, Nakada SY
Flexible and rigid cystoscopy in women. JSLS. 2009 Apr-Jun;13(2):135-8.
Kadi N, Menezes P
ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19.
Miner N, Harris V, Lukomski N, Ebron T
Rinsability of orthophthalaldehyde from endoscopes. Diagn Ther Endosc. 2012;2012:853781. doi: 10.1155/2012/853781. Epub 2012 May 16.
O'Sullivan DC, Chilton CP
Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5. Review.
Pillai PL, Sooriakumaran P
Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. Review.
Samplaski MK, Jones JS
Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8.
Sokol WN
Nine episodes of anaphylaxis following cystoscopy caused by Cidex OPA (ortho-phthalaldehyde) high-level disinfectant in 4 patients after cytoscopy. J Allergy Clin Immunol. 2004 Aug;114(2):392-7.

Clinical Investigation to Evaluate the Effectiveness of the Ambu® aScope™ 4 Cysto With the Ambu® aView™ 2 Advance for Flexible Cystoscopy

Clinical trial NCT04829461 - References