NCT02140476 - 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)

Janssen PF, Brölmann HA, Huirne JA
Effectiveness of electrothermal bipolar vessel-sealing devices versus other electrothermal and ultrasonic devices for abdominal surgical hemostasis: a systematic review. Surg Endosc. 2012 Oct;26(10):2892-901. Epub 2012 Apr 27. Review.
Newcomb WL, Hope WW, Schmelzer TM, Heath JJ, Norton HJ, Lincourt AE, Heniford BT, Iannitti DA
Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surg Endosc. 2009 Jan;23(1):90-6. doi: 10.1007/s00464-008-9932-x. Epub 2008 May 16.
Person B, Vivas DA, Ruiz D, Talcott M, Coad JE, Wexner SD
Comparison of four energy-based vascular sealing and cutting instruments: A porcine model. Surg Endosc. 2008 Feb;22(2):534-8. Epub 2007 Dec 20.

Comparative Analysis Between A Bipolar Vessel Sealing and Cutting Device and the Tie and Suture Technique in Thyroidectomy: A Two Institution Randomized Clinical Trial

Details for clinical trial NCT02140476

Clinical trial NCT02140476 - References