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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT03959878
Status
Recruiting
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Conditions

  • Gastrostomy

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 30, 2019
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Gastrostomy Tube
    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.

Primary Outcome Measure

Constant Pressure Skin Disk (CPSD) durability [ Time Frame: 180 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Paul A Lorentz, MS, RN, RD
[email protected]
507-255-7121
Manpreet Mundi, MD (PRINCIPAL_INVESTIGATOR)
Paul Lorentz, MS, RN, RD (SUB_INVESTIGATOR)

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