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

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ClinicalTrials.gov Identifier: NCT03959878
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Manpreet S. Mundi, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Gastrostomy Device: Constant Pressure Skin Disk Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Constant Pressure Skin Disk (CPSD) durability [ Time Frame: 180 days ]
    Number of devices that remain intact


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 180 days ]
    Number of adverse events reported



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959878


Contacts
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Contact: Paul A Lorentz, MS RN RD 507-255-7121 lorentz.paul@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Paul A Lorentz, MS, RN, RD    507-255-7121    lorentz.paul@mayo.edu   
Principal Investigator: Manpreet Mundi, MD         
Sub-Investigator: Paul Lorentz, MS, RN, RD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Manpreet S Mundi, MD Mayo Clinic

Additional Information:
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Responsible Party: Manpreet S. Mundi, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03959878     History of Changes
Other Study ID Numbers: 16-001922
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Manpreet S. Mundi, Mayo Clinic:
Jejunostomy