Stopped: Voluntary pause in enrollment to revise inclusion criteria and need for reliable transportation, after one unanticipated problem with a participant who had challenges attending safety clinical visits.
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 tube. This accessory has been developed by the Cleveland Clinic and will be used for the first time in human subjects according to the labeled indication for clinical use in accordance with the Manufacturer's Instructions for Use based on other similar, FDA approved gastrostomy and jejunostomy enteral feeding tube accessory components. After providing informed consent, eligible patients will receive a study stoma site accessory during a feeding tube replacement procedure the patient is scheduled to have as a standard of care procedure.
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Successful Accessory Placement
Timeframe: Week 2 Visit
Successful Accessory Placement
Timeframe: Week 4 Phone call
Successful Accessory Placement
Timeframe: Week 6 Phone call
Successful Accessory Placement
Timeframe: Month 3 Visit
Successful Accessory Placement
Timeframe: Month 4 Visit
Successful Accessory Placement
Timeframe: Month 6 Visit
Number of Participants With a Feeding Tube Complication With a Study Accessory
Timeframe: Baseline
Number of Participants With a Feeding Tube Complication With a Study Accessory
Timeframe: Week 2 Visit
Number of Participants With a Feeding Tube Complication With a Study Accessory
Timeframe: Month 3 Visit
Number of Participants With a Feeding Tube Complication With a Study Accessory
Timeframe: Early termination (during the first 6 months)
Number of Participants With a Feeding Tube Complication With a Study Accessory
Timeframe: Month 6 Visit