Safety and Efficacy of Enteral Feeding Tube Stoma Site Accessory

Unknown Not Applicable NCT05288556

Study Description

A study is being conducted to measure the safety and effectiveness of the Enteral Feeding Tube Stoma Site Accessory in preventing abdominal wall leakage in patients with long-term feeding tubes. The accessory is developed by Cleveland Clinic to be used according to the labeled indication and FDA approved. Eligible patients will receive the accessory during a feeding tube replacement procedure. The study will take place over a period of 6 months, and patients will be asked to participate in quality of life questionnaires. The study accessory does not pose a significant risk to users and is made from FDA-cleared materials.

Study Details

Registry ID:
NCT05288556
Conditions:
Feeding Tube Complication
Phase:
Not Applicable
Target Enrollment:
5 participants
Start Date:
Age Range:
22–85 years
Healthy Volunteers:
No

Study Locations (1 site)

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