3D Printed Personalized Ostomy Appliance

Description

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

Conditions

3D Printing, Ostomy, Leakage

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Study Overview

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Study Details

Study overview

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

3D Printed Personalized Ostomy Appliance

3D Printed Personalized Ostomy Appliance

Condition
3D Printing
Intervention / Treatment

-

Contacts and Locations

Roanoke

Carilion Clinic, Roanoke, Virginia, United States, 24013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18-100 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.
  • * 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.
  • * Diagnosis of infection around the peristomal region. (erythema is NOT an exclusion criteria)

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Carilion Clinic,

Farrell Adkins, MD, PRINCIPAL_INVESTIGATOR, Carilion Clinic

Study Record Dates

2025-06-05