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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT04577456
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 21 years
* Able to provide written informed consent
* Dependent on parenteral nutrition (PN)
* DES/ECF with exposed afferent and efferent limbs visible on the abdominal wall
* Minimum of 2 weeks post DES/ECF creation
* Distal limb of DES/ECF opening can be intubated by a minimum 24Fr feeding tube (dilatation of orifice strictures is allowable)
Exclusion Criteria:
* Insufficient distal access channel (distal limb) for device insertion
* Bowel obstruction proximal to the DES/ECF
* Small bowel obstruction, anastomotic leak, or perforation distal to the DES/ECF (diagnostic procedure such as gastrografin test, fistulograms, or similar must be performed, if there is a distal anastomosis with integrity not previously evaluated, to ensure that the subject is eligible)
* Scheduled for DES/ECF reversal within 4 weeks of enrolment date
* Current infection with Clostridium difficile colitis
* Current infection small intestinal bacterial overgrowth (SIBO)
* Signs or symptoms of systemic infection
* Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis
* Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson's disease, hypothyroidism
* Known peritoneal metastatic disease prior to DES/ECF closure (acceptable if only discovered at time of closure)
* Liver cirrhosis
* Hereditary coagulopathy, e.g., von Willebrand disease
* Severe chronic renal insufficiency prior to DES/ECF formation (eGFR\<30mL/min/1.73m2)
* Active implantable medical devices such as neuromodulation and cardiac systems
* Metal stents implanted within 20cm of expected use of the controller
* Women who are pregnant or breastfeeding
* Subjects participating in an interventional clinical study within 30 days prior to randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04577456
Study Brief:
Protocol Section:
NCT04577456