3D Printed Personalized Ostomy Appliance

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Carilion Clinic
Study ID
NCT06310070
Status
Recruiting
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Conditions

  • 3D Printing
  • Leakage
  • Ostomy

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • 3D Printed Personalized Ostomy Appliance — DEVICE
    Study procedures will include getting your stoma scanned, receiving personalized ostomy appliances in the mail, receiving a personalized ostomy template, which will be printed using a 3D printer, in the mail, and completing a daily symptom diary along with a weekly survey for 4 weeks.3D printing is done using a machine that takes the 3D image from the computer and prints a replica of the image using plastic or other materials.

Study Details

The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is: • Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance. Participants will * Spend 2 weeks with their standard of care ostomy appliance * Spend 2 weeks with their personalized ostomy appliance made from a 3D scan * Participate in daily surveys and weekly quality of life surveys conducted over the phone

Key Dates

Start date
May 10, 2024
Status verified
Jan 2025
Primary completion
Mar 5, 2025
Completion
Jun 5, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Receiving 3D Personalized Ostomy Appliance
    The personalized ostomy appliances are designed based off of a 3D scan. We will scan your ostomy to create a 3D picture in the computer system that is an exact copy of your ostomy using plastic. We then apply computer aided design (CAD) tools to modify your normal ostomy baseplates.

Primary Outcome Measure

Incidence of Leaks [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carilion ClinicRoanokeVirginia24013
Adam Goode, MD
[email protected]

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By research site
Carilion Clinic· Roanoke, VA

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