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

ConditionGastrostomy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22+

SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than or equal to 22 years

Undergoing PEG tube or PEJ tube placement

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Gastrostomy TubeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Constant Pressure Skin Disk (CPSD) durability

Number of devices that remain intact

Time frame

180 days

Secondary outcomes

Adverse Events

Number of adverse events reported

Time frame

180 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

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