Home › NCT06310070

3D Printed Personalized Ostomy Appliance

Who can join

Ages 18 to 100 · All sexes · Healthy volunteers welcome

Inclusion 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.

Exclusion Criteria:

* 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)

About the study

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

What is being tested

• 3D Printed Personalized Ostomy Appliance (device)

Sponsor: Carilion Clinic · Participants: 30 · Started: May 10, 2024

Contact the study team

• Adam Goode, MD · Phone: 540-224-5170

Official record on ClinicalTrials.gov — NCT06310070

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.