Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique

Study Overview
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Brief Summary
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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.

Official Title
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A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique

Conditions
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Gastrostomy

Intervention / Treatment
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* Device: PUG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •Written informed consent must be obtained before any study-specific assessment is performed •Male or female ≥18 years of age•BMI between 20 and 30•Indication for gastrostomy tube placement determined to be present by the primary clinical care team•Patient determined to be an appropriate candidate for PEG or PUG by the study team•Women of childbearing potential must have negative serum or urine pregnancy test duringthe current hospitalization Exclusion Criteria: •BMI <20 or > 30•Temperature ≥ 38 C •Systolic BP < 100 or > 180 mmHg•Heart Rate < 50 or > 110•Presence of a contraindication to being in proximity to a magnet (e.g. pacemaker).•History of prior gastrostomy or gastrectomy (partial or complete).•Patients with hematocrit <25%, or a history of blood transfusion within the 14 days prior to screening, or active life-threatening GI bleeding. •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. •Involvement in other investigational trials within 30 days prior to screening.•Any other medical condition(s) that may putthe patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational PUG<br>Patients receive gastrostomy via percutaneous ultrasound gastrostomy. | Device: PUG<br>* This methodology involves using ultrasound to place gastrostomy tube (g-tube itself is off the shelf).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success of PUG | proportion of PUG procedures that result in successful placement of a gastrostomy tube | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 30 days |