Personalized 3D Printed Ostomy Appliance
Official title: 3D Printed Personalized Ostomy Appliance
Run by Carilion Clinic · NCT06310070 · Data updated 2026-11-12
This study is testing if a custom 3D printed ostomy appliance can help people with ostomies feel more comfortable and satisfied compared to their regular appliance.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Carilion Clinic Academic / other |
| Locations | 1 site (Roanoke, Virginia) |
| Status | Recruiting |
| Started | May 10, 2024 |
| Main results expected | March 5, 2025 |
| Study ends | June 5, 2025 |
| Registry record updated | January 22, 2025 |
| Trial ID | NCT06310070 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-100 who have been using an ostomy appliance for more than six weeks and have experienced leakage issues.
✕Probably not a fit
Patients who have existing peri-stomal skin breakdown or infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of a personalized ostomy appliance created using 3D scanning technology. Participants will first use their standard ostomy appliance for two weeks, followed by a two-week period with a custom 3D printed appliance designed from a scan of their stoma. The study will involve daily surveys and weekly quality of life assessments conducted via phone to measure the impact of the personalized appliance on leakage and overall patient satisfaction. The goal is to determine if this innovative approach can reduce complications and improve the quality of life for ostomy patients.
Why it matters
Potential benefit: If successful, this approach could significantly reduce leakage issues and enhance the quality of life for patients with ostomies.
How similar studies have gone: While the use of 3D printing in medical applications is growing, this specific approach to creating personalized ostomy appliances is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Carilion Clinic
Roanoke, Virginia, United States Recruiting
Study contacts
- Principal investigator: Farrell Adkins, MD — Carilion Clinic
- Study coordinator: Adam Goode, MD
- Email: aegoode@carilionclinic.org
- Phone: 540-224-5170
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.