Actively Recruiting
3D Printed Personalized Ostomy Appliance
Led by Carilion Clinic · Updated on 2025-01-22
30
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
C
Carilion Clinic
Lead Sponsor
V
Virginia Polytechnic Institute and State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
3D Printed Personalized Ostomy Appliance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18-100 years old
- Must have used current ostomy appliance for more than 6 weeks
- Must have experienced more than 1 leakage in the week before consenting
- Must be able to consent for themselves
- Must have access to a phone and a computer with internet and be able to provide an email address for electronic consent and surveys
You will not qualify if you...
- Concern about ability to be reached by phone or reliable internet access for survey completion
- Existing peristomal skin breakdown including ulceration or mucocutaneous separation
- Diagnosis of infection around the peristomal region (erythema is not an exclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Carilion Clinic
Roanoke, Virginia, United States, 24013
Actively Recruiting
Research Team
A
Adam Goode, MD
CONTACT
U
Uma Kelavkar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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