Actively Recruiting
Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes
Led by Mayo Clinic · Updated on 2026-01-26
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 22 years
- Undergoing placement of a percutaneous endoscopic gastrostomy (PEG) tube or percutaneous endoscopic jejunostomy (PEJ) tube
You will not qualify if you...
- History of tobacco or illegal drug use in the past year
- History of a previous enteral feeding tube
- History of gastric surgery such as bariatric surgery or Nissen fundoplication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of tube placement
Participants undergo placement of a gastrointestinal gastrostomy or jejunostomy tube during which the usual skin disk is replaced with the Constant Pressure Skin Disk (CPSD) by the gastroenterologist or interventional radiologist.
1 procedure visit (in-person)
Duration - Up to 180 days
Participants are monitored for the durability of the Constant Pressure Skin Disk and any adverse events following placement.
Follow-up visits as per routine care
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
P
Paul A Lorentz, MS RN RD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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