Testing a new skin disk for feeding tubes
Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.
NA · Mayo Clinic · NCT03959878
This study is testing a new adjustable skin disk for feeding tubes to see if it helps people heal better and have fewer problems than the standard option.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT03959878 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of a new adjustable skin disk, known as the Constant Pressure Skin Disk (CPSD), used in conjunction with gastrostomy and jejunostomy feeding tubes. Researchers will replace the standard external skin disk with the CPSD during the tube placement procedure to assess its effectiveness in promoting healing and reducing complications. The study aims to gather data on the safety and efficacy of this new device compared to traditional options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who are undergoing placement of a PEG or PEJ tube.
Not a fit: Patients with a history of tobacco or illegal drug use, prior enteral tube placement, or certain gastric surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved healing and fewer complications for patients requiring enteral feeding.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving outcomes with new devices in enteral feeding.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Manpreet S Mundi, MD — Mayo Clinic
- Study coordinator: Paul A Lorentz, MS RN RD
- Email: lorentz.paul@mayo.edu
- Phone: 507-255-7121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrostomy, Jejunostomy