NCT01553331 - 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)

Cengiz Y, Dalenbäck J, Edlund G, Israelsson LA, Jänes A, Möller M, Thorell A
Improved outcome after laparoscopic cholecystectomy with ultrasonic dissection: a randomized multicenter trial. Surg Endosc. 2010 Mar;24(3):624-30. doi: 10.1007/s00464-009-0649-2. Epub 2009 Aug 18.
Cengiz Y, Jänes A, Grehn A, Israelsson LA
Randomized trial of traditional dissection with electrocautery versus ultrasonic fundus-first dissection in patients undergoing laparoscopic cholecystectomy. Br J Surg. 2005 Jul;92(7):810-3.

Day Case Laparoscopic Cholecystectomy: Comparison of Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook, Randomized Trial

Clinical trial NCT01553331 - References