Clinical Trials Directory

Trials / Unknown

UnknownNCT06095804

Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure

A Single Center, Pilot Study to Evaluate the Feasibility of the Percutaneous Ultrasound Jejunostomy (PUJ)

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
CoapTech · Industry
Sex
All
Age
22 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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).

Conditions

Interventions

TypeNameDescription
DEVICEPercutaneous Ultrasound JejunostomyPlacement of a jejunostomy tube using the PUMA-J System

Timeline

Start date
2023-12-01
Primary completion
2025-06-01
Completion
2025-07-01
First posted
2023-10-23
Last updated
2023-10-23

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06095804. Inclusion in this directory is not an endorsement.