NCT01115010 - 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)

Baron TH
The variable stiffness colonoscope: a scope for all seasons? Am J Gastroenterol. 2002 Dec;97(12):2942-3. Review.
Odori T, Goto H, Arisawa T, Niwa Y, Ohmiya N, Hayakawa T
Clinical results and development of variable-stiffness video colonoscopes. Endoscopy. 2001 Jan;33(1):65-9.
Othman MO, Bradley AG, Choudhary A, Hoffman RM, Roy PK
Variable stiffness colonoscope versus regular adult colonoscope: meta-analysis of randomized controlled trials. Endoscopy. 2009 Jan;41(1):17-24. doi: 10.1055/s-0028-1103488. Epub 2009 Jan 21. Erratum in: Endoscopy. 2009 Apr;41(4):315.
Shah SG, Saunders BP
Aids to insertion: magnetic imaging, variable stiffness, and overtubes. Gastrointest Endosc Clin N Am. 2005 Oct;15(4):673-86. Review.
Sivak MV
Gastroenterologic Endoscopy. Second Edition. W.B. Saunders, 1999.
Smith PG, Morrow RH
Field Trials of Health Interventions in Developing Countries: A Toolbox. 2nd ed. London: Macmillan Education, 1996.
Zutron Medical
Colonoscope stiffening device. http://zutronmedical.storesecured.com/items/Endoscope-Stiffening-System/list.htm . 2009. Ref Type: Electronic Citation

Effectiveness of a Proprietary Intraluminal Stiffening Wire in Decreasing Procedure Time and Improving Cecal Intubation Rate With Pre-owned Colonoscopes; a Randomized, Controlled Trial

Details for clinical trial NCT01115010

Clinical trial NCT01115010 - References