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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastrostomy

Intervention / Treatment
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* Device: Constant Pressure Skin Disk


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastrostomy Tube<br>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. | Device: Constant Pressure Skin Disk<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Pressure Skin Disk (CPSD) durability | Number of devices that remain intact | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events reported | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jejunostomy