Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Jejunostomy; Complications, Enteral and Supplement Feeds Adverse Reaction, Safety Issues

Intervention / Treatment
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* Device: Percutaneous Ultrasound Jejunostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent must be obtained before any study-specific assessment is performed Male or female > 21 years of age Estimated tract length (skin to anterior abdominal wall) <= 4.5cm on prior imaging Indication for percutaneous jejunostomy tube placement determined to be present by the primary clinical care team (examples below): High aspiration risk Malnourished- chronically ill and/or neurologically impaired requiring jejunal feeding for >30 Days. Neoplasia (stomach and esophagus) Gastric and duodenal obstruction Gastrointestinal dysmotility (gastroparesis) Altered anatomy (gastric-esophageal surgeries) Other indication deemed to be appropriate by the study team Patient determined to be an appropriate candidate for percutaneous jejunostomy by the study team Women of childbearing potential must have negative serum or urine pregnancy test during the current hospitalization Exclusion Criteria: Temperature ≥ 38 C Systolic BP < 90 or > 180 mmHg Heart Rate < 50 or > 120 Presence of a contraindication to being in proximity to a magnet (e.g. pacemaker) History of prior major abdominal surgery Patients with HgB < 7g/dL, or fluid resuscitated within 48hrs prior, or history of life-threatening gastrointestinal bleeding within 1 month Pregnant or nursing (lactating) women Involvement in other investigational trials within 30 days prior to screening Absolute contraindications: Sepsis Severe ascites Peritonitis Coagulopathy (international normalized ratio (INR) greater than 1.5 or a platelet count of less than 50,000/uL) Abdominal wall infection at the site of planned tube insertion Interposed organs as determined by imaging Abnormal upper gastrointestinal anatomy (e.g., partial or Total gastrectomy, Esophageal strictures) Inflammatory, or infiltrative diseases of the small bowel and/or anterior abdominal wall. Other standard general contraindications to endoscopy Pacemakers or other electronically active implantable devices Small bowel fistula Any other medical condition(s) that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Ultrasound Jejunostomy<br>Placement of a longterm jejunostomy tube using the PUMA-J System | Device: Percutaneous Ultrasound Jejunostomy<br>* Placement of a jejunostomy tube using the PUMA-J System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Rate of procedural success in completing jejunostomy tube placement using the PUMA-J System | Procedure timeframe | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Aborts | Description of occurrences of procedure abort | Procedure timeframe | 
| Device Related Serious Adverse Events | Rate of Device Related Adverse Events following Jejunostomy procedure | 48 hours of procedure performance | 
| Adverse Events | Rate of all Adverse Events following Jejunostomy procedure | 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 | Procedure timeframe | 
| Requirement for salvage surgery due to complication of the procedure | Description of occurrences of salvage surgery performed due to complication of procedure | 48 hours of procedure performance | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jejunostomy, Enteral Feeding, Long-term Enteral Nutrition