Percutaneous ultrasound gastrostomy (PUG): first prospective clinical trial.

ABSTRACT:

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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/m²). 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/m²). Primary outcomes included successful insertion and 30-day procedure-related adverse events (AE's). Secondary outcom

SUBMITTER: Accorsi F 

PROVIDER: S-EPMC8502161 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature