3D Printed Personalized Ostomy Appliance
Recruiting now · Not applicable
Conditions studied: 3D Printing, Ostomy, Leakage
In brief
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 facts
- Study ID
- NCT06310070
- Run by
- Carilion Clinic
- People needed
- 30
- Starts
- 2024-05-10
- Expected to finish
- 2025-06-05
- Last updated by the study team
- 2025-01-22
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Carilion Clinic — Roanoke, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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