Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure

Launched by COAPTECH · Oct 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called the Percutaneous Ultrasound Jejunostomy (PUJ), which helps place a feeding tube in the small intestine using ultrasound technology. The goal is to see how well this procedure works and if it is safe for patients who need this type of feeding, especially those with conditions that make it hard for them to eat normally. The trial will involve up to 10 patients, and they will be monitored for two days after the procedure to check for any complications.

To participate in this study, candidates must be at least 21 years old and have specific medical reasons for needing the feeding tube, like being at high risk for choking or requiring long-term feeding due to illness. However, certain health issues, like fever or recent major surgeries, will exclude patients from joining. This trial is not yet recruiting, so interested individuals will need to wait for further announcements. Overall, this study aims to improve how patients receive nutrition when they cannot eat by mouth, helping to ensure their health and well-being.

Gender

ALL

Eligibility criteria

• 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.