NCT03053232 - 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)

Schultz JK, Yaqub S, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Körner H, Dahl FA, Øresland T; SCANDIV Study Group
. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1364-75. doi: 10.1001/jama.2015.12076.
Tan S, Wu G, Zhuang Q, Xi Q, Meng Q, Jiang Y, Han Y, Yu C, Yu Z, Li N
Laparoscopic versus open repair for perforated peptic ulcer: A meta analysis of randomized controlled trials. Int J Surg. 2016 Sep;33 Pt A:124-32. doi: 10.1016/j.ijsu.2016.07.077. Review.

Purse String Suture Device Versus Endoclip in the Treatment of Immediate Endoscopic Procedure Associated Gastrointestinal Perforation

Clinical trial NCT03053232 - References