Thompson CC, Jirapinyo P, McCarty TR, Brethauer S, Shaheen N, Sullivan SA et al.
Ann Surg 2026; 284: 34-42.
Some 320 patients were included and the liner group had a greater drop in HbA1c at 12 months (-1.10 versus -0.28 per cent, P=0.0004), with greater total weight loss (7.7 versus 2.1 per cent, P<0.0001) and more patients reaching HbA1c ≤7 per cent (28.3 versus 9.4 per cent, P<0.0003) and ≥5 per cent weight loss (60.4 versus 21.3 per cent, P<0.0001). Device-related serious adverse events occurred in 9.4 per cent, including intolerance (3.7 per cent), haemorrhage (2.8 per cent), and hepatic abscess (2.3 per cent).
Comment: A rare, well-run sham-controlled device trial with a clean efficacy signal, though important risk of device-related adverse events.
Comment by Jeongyoon (Jenny) Moon, MD
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