NCT02308631 - 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)

Hellinger MD, Martinez SA, Parra-Davila E, Yeguez J, Sands LR
Gasless laparoscopic-assisted intestinal stoma creation through a single incision. Dis Colon Rectum. 1999 Sep;42(9):1228-31.
Mattingly M, Wasvary H, Sacksner J, Deshmukh G, Kadro O
Minimally invasive, endoscopically assisted colostomy can be performed without general anesthesia or laparotomy. Dis Colon Rectum. 2003 Feb;46(2):271-3.
Senapati A, Phillips RK
The trephine colostomy: a permanent left iliac fossa end colostomy without recourse to laparotomy. Ann R Coll Surg Engl. 1991 Sep;73(5):305-6.

ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY FOR CRITICALLY ILL PATIENTS WITHOUT GENERAL ANESTHESIA OR LAPAROTOMY. EXPERIMENTAL STUDY

Clinical trial NCT02308631 - References