Single-center, Feasibility Study to Evaluate the Use and Safety of the Percutaneous Ultrasound Gastrostomy Technique
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03956277|
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : February 18, 2022
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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 :||August 1, 2022|
|Estimated Study Completion Date :||December 30, 2022|
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 Medical System|