Abstract
GRAPHICAL ABSTARCT: PURPOSE: To report the results of the first-in-human trial evaluating the safety and efficacy of the percutaneous ultrasound gastrostomy (PUG) technique. METHODS: A prospective, industry-sponsored single-arm clinical trial of PUG insertion was performed in 25 adult patients under investigational device exemption (mean age 64 ± 15 years, 92% men, 80% inpatients, mean BMI 24.5 ± 2.7 kg/m(2)). A propensity score-matched retrospective cohort of 25 patients who received percutaneous radiologic gastrostomy (PRG) was generated as an institutional control (mean age 66 ± 14 years, 92% men, 80% inpatients, mean BMI 24.0 ± 2.7 kg/m(2)). Primary outcomes included successful insertion and 30-day procedure-related adverse events (AE's). Secondary outcomes included procedural duration, sedation requirements, and hospital length of stay. RESULTS: All PUG procedures were successful, including 3/25 [12%] performed bedside within the ICU. There was no significant difference between PUG and PRG in rates of mild AE's (3/25 [12%] for PUG and 7/25 [28%] for PRG, p = 0.16) or moderate AE's (1/25 [4%] for PUG and 0/25 for PRG, p = 0.31). There were no severe AE's or 30-day procedure-related mortality in either group. Procedural room time was longer for PUG (56.5 ± 14.1 min) than PRG (39.3 ± 15.0 min, p < 0.001). PUG procedure time was significantly shorter after a procedural enhancement, the incorporation of a Gauss meter to facilitate successful magnetic gastropexy. Length of stay for outpatients did not significantly differ (2.4 ± 0.5 days for PUG and 2.6 ± 1.0 days for PRG, p = 0.70). CONCLUSION: PUG appears effective with a safety profile similar to PRG. Bedside point-of-care gastrostomy tube insertion using the PUG technique shows promise. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID NCT03575754.