Recruiting

CPSD

Sponsor:

Mayo Clinic

Code:

NCT03959878

Conditions

Gastrostomy

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Constant Pressure Skin Disk

Study Details

Brief 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.

Conditions

Gastrostomy

Study ID

NCT03959878

Start date

Sep 30, 2019

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Gastrostomy Tube

Non-hospitalized outpatients undergoing placement of a gastrointestinal gastrostomy tube (GIG tube) or GI jejunostomy tube (GIJ tube) will receive the usual Standards of Care related to the placement of a GIG or GIJ tube and the Constant Pressure Skin Disk.

Interventions

Constant 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.

Primary outcome measure

  • Constant Pressure Skin Disk (CPSD) durability [ Time Frame: 180 days ]

Central Contacts and Locations

Central contacts

Paul A Lorentz, MS RN RD

507-255-7121lorentz.paul@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Paul A Lorentz, MS, RN, RD

507-255-7121lorentz.paul@mayo.edu

Principal Investigator:

Manpreet Mundi, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • Jejunostomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-26.