NCT04671771 - 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)

Gage SM, Illig KA, Ross JR
Use of a novel immediate access dialysis graft designed to prevent needle-related complications: A first-in-man case report. J Vasc Access. 2021 May;22(3):475-479. doi: 10.1177/1129729820917265. Epub 2020 May 5.
Gage SM, Lawson M, Nichols C, Sycks D, Manson RJ, Knight JA
An immediate access dialysis graft designed to prevent needle-related complications: Results from the initial pre-clinical studies. J Vasc Access. 2020 May;21(3):328-335. doi: 10.1177/1129729819874987. Epub 2019 Sep 16.

A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease

Clinical trial NCT04671771 - References