Status:
UNKNOWN
Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure
Lead Sponsor:
CoapTech
Collaborating Sponsors:
University of Maryland, Baltimore
Conditions:
Jejunostomy; Complications
Enteral and Supplement Feeds Adverse Reaction
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 wid...
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 g...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06095804
Start Date
December 1 2023
End Date
July 1 2025
Last Update
October 23 2023
Active Locations (1)
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1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201