NCT00166205 - 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)

Phillips E, Ponce J, Cunneen SA, Bhoyrul S, Gomez E, Ikramuddin S, Jacobs M, Kipnes M, Martin L, Marema RT, Pilcher J, Rosenthal R, Rubenstein R, Teixeira J, Trus T, Zundel N
Safety and effectiveness of Realize adjustable gastric band: 3-year prospective
Phillips E; SAGB Study Group
Design and demography of the United States Swedish Adjustable Gastric Band trial: a 3-year prospective study. Surg Obes Relat Dis. 2008 May-Jun;4(3 Suppl):S63-72. doi: 10.1016/j.soard.2008.04.009.

A Single-Arm, Multi-Center Study of the Safety and Effectiveness of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity

Clinical trial NCT00166205 - References