RecruitingNot ApplicableNCT06310070

3D Printed Personalized Ostomy Appliance

Sponsor

Carilion Clinic

Enrollment

30 participants

Start Date

May 10, 2024

Study Type

INTERVENTIONAL

Conditions

Ostomy 3D Printing Leakage

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria5

years old
Must have had current ostomy appliance for \> 6 weeks - if patients with stomas less than 6 weeks are included, their personalized templates will not be useful once the stoma size has changed after their initial scan.
Must have experienced \> 1 leakage in the week leading up to day of consent. - If patients are not experiencing leakages, then there will be no baseline data to compare effectiveness of the post-3D appliance intervention.
Participants must be able to consent for themselves
Access to phone AND computer with internet access. Patient must be able to provide electronic mailing address for e-consent documentation and REDCap surveys.

Exclusion Criteria2

Concern for patient being able to be reached over the phone or reliable internet access for REDCap survey completion
Existing peri-stomal skin breakdown including ulceration or mucocutaneous separation.

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Interventions

DEVICE3D Printed Personalized Ostomy Appliance

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.