We tested whethera 3D-printed cap delivers non-inferior efficiency with superior handling versus a standard commercial cap in the multicenter ENDOPRINT trial (ex vivo porcine models) which took place in Prague and Olomouc (Czech Republic) and Boston (USA). 

Across three centers, 99 ESDs (33/site) were randomized 1:1 to a 3D-printed or commercial cap (Olomouc 20/13; Prague 15/18; Boston 16/17). The primary endpoint was procedure time.The secondary endpoints were lesion size, en-bloc resection rate, ergonomics, scope withdrawal for cleaning/exchange, and adverse events. The 3D-printed cap was createdon Form 3B using BioMed Flex 80A.

Procedure time was the same for both caps (median 17.3 min; p=0.952); technical and en-bloc resection rates were the same (100%). Ergonomic parameters favored the 3D-printed cap (visibility 4 vs 3; manipulation 4 vs 3; retraction 5 vs 3; all p<0.001) and were replicated at each center. Adverse events were rare and similar (tears 4 vs 3; perforation 0 vs 1). Lesion size correlated with time (ρ=0.44; p=0.001), center effects, not cap type, explained time variability. 

Custom 3D-printed distal attachment caps are non-inferior for speed and safety; however, 3D caps provide superior visibility and traction. These data support rapid, design-tailored, cost-efficient accessories for ESD and training. Clinical in vivo validation and economic analyses are warranted.