NCT03959878

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrostomy

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2019-09-30
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2019-05-22
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study