Testing a New Constant Pressure Skin Disk Device for Feeding Tubes in Adults Undergoing Gastrostomy or Jejunostomy Tube Placement

What this Trial Is About

Researchers are studying a new type of adjustable skin disk called the Constant Pressure Skin Disk CPSD for use with feeding tubes placed in the stomach or small intestine, such as gastrointestinal gastrostomy GIG or jejunostomy GIJ tubes. The study aims to find out if the CPSD supports proper healing and reduces complications compared to the usual external skin disks. This research is led by Mayo Clinic and involves outpatient adults who need these feeding tubes. During the feeding tube placement procedure, a gastroenterologist or interventional radiologist will replace the standard adjustable skin disk with the CPSD by sliding the original disk off and sliding the CPSD onto the tube. Participants will receive regular care for their tube placement along with the CPSD device. The study focuses on the durability of the CPSD over 180 days and monitors any adverse events during this period. Participants will be followed for six months after placement to assess how well the CPSD holds up and to track any complications. Researchers will evaluate device durability and record any side effects or problems related to the CPSD. The study involves regular assessments during this time to gather safety and performance data, helping to understand if the CPSD could be a better option for patients needing feeding tubes.

Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.