NCT03146299 - 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)

Carter JE, Ryoo J, Katz A
Laparoscopic-assisted vaginal hysterectomy: a case control comparative study with total abdominal hysterectomy. J Am Assoc Gynecol Laparosc. 1994 Feb;1(2):116-21.
Dicker RC, Greenspan JR, Strauss LT, Cowart MR, Scally MJ, Peterson HB, DeStefano F, Rubin GL, Ory HW
Complications of abdominal and vaginal hysterectomy among women of reproductive age in the United States. The Collaborative Review of Sterilization. Am J Obstet Gynecol. 1982 Dec 1;144(7):841-8.
Hwang JL, Seow KM, Tsai YL, Huang LW, Hsieh BC, Lee C
Comparative study of vaginal, laparoscopically assisted vaginal and abdominal hysterectomies for uterine myoma larger than 6 cm in diameter or uterus weighing at least 450 g: a prospective randomized study. Acta Obstet Gynecol Scand. 2002 Dec;81(12):1132-8.

Comparison of Total Laparoscopic Hysterectomy and Laparoscopic Assisted Vaginal Hysterectomy With Over Giant Uterus of Than 500g: A Randomized Controlled Trial

Details for clinical trial NCT03146299

Clinical trial NCT03146299 - References