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| Name | Class |
|---|---|
| University of Maryland, Baltimore | OTHER |
| University of Maryland, Baltimore Washington Medical Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational PUG | Patients receive gastrostomy via percutaneous ultrasound gastrostomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PUG | Device | This methodology involves using ultrasound to place gastrostomy tube (g-tube itself is off the shelf). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success of PUG | proportion of PUG procedures that result in successful placement of a gastrostomy tube | Immediate |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who meet the inclusion and exclusion criteria who are indicated for gastrostomy
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| Name | Affiliation | Role |
|---|---|---|
| Gentry Wilkerson | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21202 | United States |
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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 |