Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
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|ClinicalTrials.gov Identifier: NCT03956277|
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : July 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastrostomy||Device: PUG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique|
|Actual Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||May 30, 2021|
|Estimated Study Completion Date :||May 30, 2021|
Experimental: Observational PUG
Patients receive gastrostomy via percutaneous ultrasound gastrostomy.
This methodology involves using ultrasound to place gastrostomy tube (g-tube itself is off the shelf).
- Technical Success of PUG [ Time Frame: Immediate ]proportion of PUG procedures that result in successful placement of a gastrostomy tube
- SAE Rate [ Time Frame: 30 days ]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.
- Complication Rate [ Time Frame: 30 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956277
|Contact: Jack Kentemail@example.com|
|United States, Maryland|
|University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21202|
|Contact: Richard G Wilkerson, MD 410-328-4237 GWilkerson@som.umaryland.edu|
|Principal Investigator:||Gentry Wilkerson||University of Maryland, College Park|