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3D Printed Personalized Ostomy Appliance

RecruitingNAAges 18 Years - 100 YearsAllCarilion Clinic
NCT06310070 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • 3D Printed Personalized Ostomy Appliance
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Where

1 site
Carilion Clinic
Roanoke, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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