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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT05288556
Eligibility Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Male or female, aged ≥22 and ≤85 Note: Because the study accessory is designed for adult use participants \<22 years of age are excluded but will be eligible for future trials, if applicable
* Ability to understand and the willingness to sign a written informed consent document
* Patients with existing gastrostomy and jejunostomy enteral feeding tubes, placed ≥ 3 months, undergoing replacement of feeding tube inpatient or outpatient
* Willing to adhere to placement of study stoma site accessory and ability to take oral temperature at specified times
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Willing to adhere to removal of study stoma site accessory at month 6
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Patient requires general anesthesia in an OR for tube changes
* Current use of steroids (any dose) daily ≥ 3 months including, but not limited to: prednisone, prednisolone, methylprednisolone, cyclosporine
* Current use of Immunosuppressants including, but not limited to: azathioprine, mycophenolate.
* BMI ≥ 40
* Non-English speaking patients
* Pregnant Women
* Known allergic reactions to components of the study stoma site accessory \[Medical Grade Silicone\]
* Treatment with another investigational drug or device within 6 months of screening/baseline
* Uncontrolled illness, recent open abdominal surgery or social situations that in the opinion of the investigative team would limit compliance with study requirements, including, but not limited to:
* Ongoing or active infection
* Psychiatric illness
* Unable to self-report
* Not ambulatory and incapable of carrying out all self-care
* Unsuccessful stoma site study accessory placement at time of initial replacement procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT05288556
Study Brief:
Protocol Section:
NCT05288556