Status:
TERMINATED
Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory
Lead Sponsor:
Eric Yudelevich
Conditions:
Feeding Tube Complication
Eligibility:
All Genders
22-85 years
Phase:
NA
Brief Summary
The purpose of the study is to collect safety and efficacy data on the performance of the study stoma site accessory when used to prevent abdominal wall leakage for patients with a long term feeding t...
Detailed Description
The purpose of the study is to collect safety and efficacy data on the performance of the study stoma site accessory when used to prevent abdominal wall leakage for patients with a long term, ≥ 3 mont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05288556
Start Date
April 22 2022
End Date
September 11 2023
Last Update
July 25 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195