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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03959878

Enrollment

Registered

2019-05-22

Start date

2019-09-30

Completion date

2026-12-01

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrostomy

Keywords

Jejunostomy

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.

Detailed description

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.

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame	Description
Constant Pressure Skin Disk (CPSD) durability	180 days	Number of devices that remain intact

Secondary

Measure	Time frame	Description
Adverse Events	180 days	Number of adverse events reported

Countries

United States

Contacts

CONTACTPaul A Lorentz, MS RN RD

lorentz.paul@mayo.edu507-255-7121

PRINCIPAL_INVESTIGATORManpreet S Mundi, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026