NCT04344847 - 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)

Inaba CS, Dosch A, Koh CY, Sujatha-Bhaskar S, Pejcinovska M, Smith BR, Nguyen NT
Laparoscopic versus open resection of gastrointestinal stromal tumors: survival outcomes from the NCDB. Surg Endosc. 2019 Mar;33(3):923-932. doi: 10.1007/s00464-018-6393-8.
Lyros O, Moulla Y, Mehdorn M, Schierle K, Sucher R, Dietrich A
Coincidental Detection of Gastrointestinal Stromal Tumors During Laparoscopic Bariatric Procedures-Data and Treatment Strategy of a German Reference Center. Obes Surg. 2019 Jun;29(6):1858-186
Mazer L, Worth P, Visser B
Minimally invasive options for gastrointestinal stromal tumors of the stomach. Surg Endosc. 2020 Mar 27. doi: 10.1007/s00464-020-07510-x. [Epub ahead of print]

Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin

Clinical trial NCT04344847 - References