NCT02985073 - 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)

Hansson E, Burian P, Hallberg H
Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial. J Plast Surg Hand Surg. 2020 Jun;54(3):131-136.
Hansson E, Edvinsson AC, Elander A, Kölby L, Hallberg H
First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study. J Surg Oncol. 2021 Jan;123(1):80-88. doi: 10
Hansson E, Edvinsson AC, Hallberg H
Drain secretion and seroma formation after immediate breast reconstruction with a biological and a synthetic mesh, respectively: A randomized controlled study. Breast J. 2020 Sep;26(9):1756-1759. doi: 10.1111/tbj.13921
Paganini A, Meyer S, Hallberg H, Hansson E
Are patients most satisfied with a synthetic or a biological mesh in dual-plane immediate breast reconstruction after 5 years? A randomized controlled trial comparing the two meshes in the same patient. J Plast

The Gothenburg TIGR/Veritas® Study - A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction

Clinical trial NCT02985073 - References