Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT06095804
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT06095804
Study Brief:
Protocol Section:
NCT06095804