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

This study is looking at a new type of adjustable skin disk, called a Constant Pressure Skin Disk (CPSD), which is a part of a feeding tube. Researchers want to see if this new disk can help with healing and reduce problems for people who need a gastrostomy tube (G-tube) or jejunostomy tube (J-tube). You might be able to join if you are at least 22 years old and are getting a G-tube or J-tube placed for the first time. The main goal is to see how long the CPSD lasts, up to 180 days. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved
During your G-tube or J-tube placement, the manufacturer's skin disk will be replaced with the Constant Pressure Skin Disk (CPSD).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess the durability of the Constant Pressure Skin Disk (CPSD) for 180 days.

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NCT03959878

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

Recruiting
NAAges 22+InterventionalDevice feasibility
Mayo Clinic
~20 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:Constant Pressure Skin Disk

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Constant Pressure Skin Disk (CPSD) durability
Measured over 180 days
Gastrostomy
1 sites across 1 states
Minnesota1
  • Manpreet S Mundi, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

Age greater than or equal to 22 years
Undergoing PEG tube or PEJ tube placement

Exclusion

History of tobacco or illegal drug use in the past year
History of an enteral tube
History of gastric surgery (bariatric surgery, Nissen fundoplication, etc.)
  • Constant Pressure Skin Disk (CPSD) durability180 days

    Number of devices that remain intact