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NCT Number: NCT03959878

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

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.

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Key information

Conditions

Gastrostomy

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Manpreet Mundi, MD

PRINCIPAL_INVESTIGATOR

Paul A Lorentz, MS, RN, RD

CONTACT

[email protected]

507-255-7121

Paul Lorentz, MS, RN, RD

SUB_INVESTIGATOR

About this study

During the procedure of placing a gastrointestinal gastrostomy tube (GIG tube) or GI jejunostomy tube (GIJ tube), the gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, adjustable Constant Pressure Skin Disk (CPSD) by sliding the former off and the latter on to the feeding tube.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.)

Treatment and study plan

Constant Pressure Skin Disk

Device

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.

Primary outcomes

  1. Constant Pressure Skin Disk (CPSD) durability

    Time frame: 180 days

    Number of devices that remain intact

Secondary outcomes

  1. Adverse Events

    Time frame: 180 days

    Number of adverse events reported

Study contacts

Contact information is provided by the study sponsor or research team.

Paul A Lorentz, MS RN RD

CONTACT

[email protected]

507-255-7121

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
May 22, 2019
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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