NCT01558414 - 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)

Noguera J, Dolz C, Cuadrado A, Olea J, Vilella A, Morales R
Hybrid transvaginal cholecystectomy, NOTES, and minilaparoscopy: analysis of a prospective clinical series. Surg Endosc. 2009 Apr;23(4):876-81. doi: 10.1007/s00464-008-0288-z. Epub 2009 Jan 1.
Noguera JF, Cuadrado A, Sánchez-Margallo FM, Dolz C, Asencio JM, Olea JM, Morales R, Lozano L, Vicens JC
Emergency transvaginal hybrid natural orifice transluminal endoscopic surgery. Endoscopy. 2011 May;43(5):442-4. doi: 10.1055/s-0030-1256042. Epub 2010 Dec 16.
Sanchez-Margallo FM, Perez FJ, Sanchez MA, Asencio JM, del Carmen Tejonero M, Moreno C, Noguera J
Hybrid notes cholecystectomy in an experimental model of laparoscopic acute cholecystitis. Surg Laparosc Endosc Percutan Tech. 2011 Apr;21(2):e65-9. doi: 10.1097/SLE.0b013e31820a2079.

Prospective Randomized Clinical Trial Comparing Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery on Cholecystectomy

Clinical trial NCT01558414 - References