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NCT03959878 Clinical Trial

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

Gastrostomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03959878
Other study ID # 16-001922
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2019
Est. completion date December 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact Paul A Lorentz, MS RN RD
Phone 507-255-7121
Email lorentz.paul@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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.)

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Constant Pressure Skin Disk (CPSD) durability Number of devices that remain intact 180 days
Secondary Adverse Events Number of adverse events reported 180 days
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