RecruitingNot ApplicableNCT03959878

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


Sponsor

Mayo Clinic

Enrollment

20 participants

Start Date

Sep 30, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Researchers are gathering information on one specific part of a feeding tube, known as the adjustable skin disk. Researchers are trying to see if a new type of adjustable skin disk, called a Constant Pressure Skin Disk (CPSD), can safely and effectively support adequate healing, and reduced complication rates.


Eligibility

Min Age: 22 Years

Inclusion Criteria2

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

Exclusion Criteria3

  • 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.)

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Interventions

DEVICEConstant Pressure Skin Disk

The external disk is made of Dow Corning® Silastic Q7-4850 liquid silicone rubber. Placement of the disk will be done by the gastroenterologist or interventional radiologist during the gastrointestinal gastrostomy tube (GIG) or gastrointestinal jejunostomy tube (GIJ) placement procedure. The gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, adjustable Constant Pressure Skin Disk, by sliding the former off and the latter on to the feeding tube.


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT03959878


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