Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure (NCT06095804) | Clinical Trial Compass
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Clinical Pilot Study of the Percutaneous Ultrasound Jejunostomy Procedure
United States10 participantsStarted 2023-12-01
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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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
* Sever…