This is a single-center, non-randomized, non-blinded feasibility study to evaluate the performance, safety and tolerability of the Percutaneous Ultrasound Gastrostomy (PUG) procedure that utilizes a novel device in conjunction with widely available ultrasound technology. The procedure will be performed in 40eligible subjects. Patients will be followed for 2 days following performance of PUG to assess for potential complications. If the patient remains hospitalized they will be assessed through Day30 for potential complications.
Study Type
OBSERVATIONAL
Enrollment
40
This methodology involves using ultrasound to place gastrostomy tube (g-tube itself is off the shelf).
University of Maryland Medical Center
Baltimore, Maryland, United States
Technical Success of PUG
proportion of PUG procedures that result in successful placement of a gastrostomy tube
Time frame: Immediate
SAE Rate
compare the rate of serious complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using the PEG technique.
Time frame: 30 days
Complication Rate
compare the rate of other complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using the PEG technique.
Time frame: 30 days
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