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

Mayo Clinic

Status: Enrolling

Conditions: Gastrostomy

Treatments: Device: Constant Pressure Skin Disk

Study type: Interventional

Funder types: Other

Identifiers

NCT03959878

16-001922

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No 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.)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Gastrostomy Tube

Experimental group

Description:

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.

Treatment:

Device: Constant Pressure Skin Disk