Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedStudy Start
First participant enrolled
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 26, 2026
January 1, 2026
7.2 years
March 20, 2018
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Constant Pressure Skin Disk (CPSD) durability
Number of devices that remain intact
180 days
Secondary Outcomes (1)
Adverse Events
180 days
Study Arms (1)
Gastrostomy Tube
EXPERIMENTALNon-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 22 years
- Undergoing PEG tube or PEJ tube placement
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Manpreet S Mundi, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 20, 2018
First Posted
May 22, 2019
Study Start
September 30, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share