3 results
Determine the safety and preliminary efficacy of the new ACE Stapler in the specific tissue apposition application of repairing dilated post-surgical gastric anatomy over a 12 month follow-up period.
Primary goal: mean linear wear of the cross-linked polyethylene F.A.L. cup compared to the mean linear wear of the standard polyethylene F.A.L. cup at 5 years postoperatively. Secondary goals:1. mean linear wear (millimeters/year) at 1 year, 3 years…
To characterize the safety, tolerability, and recommended phase 2 dose (RP2D) of each combination partner used with ruxolitinib (Part 1)To evaluate the preliminary efficacy of each novel ruxolitinib combination treatment arm (Parts 2 & 3)