The purpose of this study is to evaluate the feasibility and performance of the Percutaneous Ultrasound Jejunostomy (PUJ) procedure that utilizes a novel device (PUMA-J System) in conjunction with widely available ultrasound technology and endoscopic guidance. The procedure will be performed in up to 10 eligible subjects. Patients will be followed for 2 days following performance of PUJ to assess for potential complications.
Jejunostomy tubes (J-tubes) provide a path for nutrition delivery directly into the small intestinal lumen, bypassing the mouth, esophagus, and stomach for patients who have difficulty with proximal gut feeding. Many medical conditions may require J-tubes, including cancers, gastroparesis, and patients with high risk of aspiration. A recent innovation by CoapTech addresses technical and procedural limitations of current jejunostomy tube placement methods by leveraging ultrasound for visualization and magnets for control of the jejunal loop. The Percutaneous Ultrasound Magnet Aligned (PUMA) System enables clinicians to affix jejunal loops superficially via magnetic coaptation and visualize the planned stomal tract using ultrasound. The purpose of this pilot clinical study is to test the feasibility of the PUMA-Jejunostomy (PUMA-J) System in adults requiring a jejunostomy tube. This is a single-center, non-randomized, non-blinded feasibility study to evaluate the performance and safety of the PUJ procedure that utilizes a novel device (PUMA-J System).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Placement of a jejunostomy tube using the PUMA-J System
University of Maryland Medical Center
Baltimore, Maryland, United States
Procedural Success
Rate of procedural success in completing jejunostomy tube placement using the PUMA-J System
Time frame: Procedure timeframe
Procedural Aborts
Description of occurrences of procedure abort
Time frame: Procedure timeframe
Device Related Serious Adverse Events
Rate of Device Related Adverse Events following Jejunostomy procedure
Time frame: 48 hours of procedure performance
Adverse Events
Rate of all Adverse Events following Jejunostomy procedure
Time frame: 48 hours of procedure performance
Rate of inadvertent puncture of vital organs
Description of occurrences of inadvertent puncture of vital organs during performance of procedure
Time frame: Procedure timeframe
Requirement for salvage surgery due to complication of the procedure
Description of occurrences of salvage surgery performed due to complication of procedure
Time frame: 48 hours of procedure performance
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