NCT00852098 - 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)

Farah JF, Grande JC, Goldenberg A, Martinez JC, Lupinacci RA, Matone J
Randomized trial of total fundoplication and fundal mobilization with or without division of short gastric vessels: a short-term clinical evaluation. Acta Cir Bras. 2007 Nov-Dec;22(6)
O'Boyle CJ, Watson DI, Jamieson GG, Myers JC, Game PA, Devitt PG
Division of short gastric vessels at laparoscopic nissen fundoplication: a prospective double-blind randomized trial with 5-year follow-up. Ann Surg. 2002 Feb;235(2):165-70.
Watson DI, Jamieson GG, Lally C, Archer S, Bessell JR, Booth M, Cade R, Cullingford G, Devitt PG, Fletcher DR, Hurley J, Kiroff G, Martin CJ, Martin IJ, Nathanson LK, Windsor JA; International Society for Diseases of the Esophagus--Australasian Section
Multicenter, prospective, double-blind, randomized trial of laparoscopic nissen vs anterior 90 degrees partial fundoplication. Arch Surg. 2004 Nov;139(11):1160-7.
Yang H, Watson DI, Lally CJ, Devitt PG, Game PA, Jamieson GG
Randomized trial of division versus nondivision of the short gastric vessels during laparoscopic Nissen fundoplication: 10-year outcomes. Ann Surg. 2008 Jan;247(1):38-42.

Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation

Details for clinical trial NCT00852098

Clinical trial NCT00852098 - References