NCT03564535 - 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)

Bresnahan E, Bates A, Wu A, Reiner M, Jacob B
The use of self-gripping (Progrip™) mesh during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: a prospective feasibility and long-term outcomes study. Surg Endosc. 2015 Sep;29(9):2690-6. doi
Buyukasik K, Ari A, Akce B, Tatar C, Segmen O, Bektas H
Comparison of mesh fixation and non-fixation in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2017 Aug;21(4):543-548. doi: 10.1007/s10029-017-1590-2. Epub 2017 Feb 18.
Garg P, Rajagopal M, Varghese V, Ismail M
Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.
Liew W, Wai YY, Kosai NR, Gendeh HS
Tackers versus glue mesh fixation: an objective assessment of postoperative acute and chronic pain using inflammatory markers. Hernia. 2017 Aug;21(4):549-554. doi: 10.1007/s10029-017-1611-1. Epub 2017 Apr 17.
Teng YJ, Pan SM, Liu YL, Yang KH, Zhang YC, Tian JH, Han JX
A meta-analysis of randomized controlled trials of fixation versus nonfixation of mesh in laparoscopic total extraperitoneal inguinal hernia repair. Surg Endosc. 2011 Sep;25(9):2849-58. doi: 10.

Comparison of Mesh Fixation With Tackers to Use of Self Fixating Mesh in Total Extra Peritoneal Inguinal Hernia Repair: A Double Blinded Randomized Controlled Trial

Details for clinical trial NCT03564535

Clinical trial NCT03564535 - References