Safety Issues Clinical Trial
Official title:
A Single Center, Pilot Study to Evaluate the Feasibility of the Percutaneous Ultrasound Jejunostomy (PUJ)
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). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04485481 -
Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers
|
Phase 1 | |
| Completed |
NCT03473236 -
Phase 1A Safety Trial of Inhaled PK10571 (GB002)
|
Phase 1 | |
| Not yet recruiting |
NCT03683953 -
The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
|
Phase 1 | |
| Recruiting |
NCT05546567 -
NOPARK Open Label Extension Study
|
N/A | |
| Recruiting |
NCT05413226 -
Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility
|
N/A | |
| Recruiting |
NCT05112159 -
Study of IPG1094 in Healthy Participants
|
Phase 1 | |
| Completed |
NCT04689035 -
A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
|
Phase 1 | |
| Completed |
NCT04335045 -
Phase I Study of PH100 (Ecklonia Cava Phlorotannins)
|
Phase 1 | |
| Completed |
NCT05037227 -
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
|
||
| Recruiting |
NCT05517291 -
DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
|
N/A | |
| Enrolling by invitation |
NCT06446778 -
Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
|
||
| Recruiting |
NCT04573049 -
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement
|
Phase 4 | |
| Completed |
NCT05585463 -
Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
|
||
| Completed |
NCT04188821 -
Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander
|
N/A | |
| Completed |
NCT03667430 -
Safety Evaluation of Porous Silica in Men
|
N/A | |
| Completed |
NCT04499482 -
Safety and Tolerability of Soy Fiber
|
N/A | |
| Completed |
NCT03141905 -
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
|
N/A | |
| Completed |
NCT05244161 -
A Quasi-experimental Evaluation of the Malezi Program in Tanzania
|
N/A | |
| Recruiting |
NCT03791372 -
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
|
Phase 1 | |
| Not yet recruiting |
NCT04774900 -
Standardization of Ambulance Equipment
|