Actively Recruiting
3D Printed Personalized Ostomy Appliance A Study to Evaluate Leak Reduction and Quality of Life Using 3D Scanning Technology
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
This research aims to evaluate whether using a 3D scan to create a personalized ostomy appliance can reduce leakages and improve quality of life for people with ostomies. Ostomy appliances collect waste from a stoma, but many patients experience issues like skin irritation, leaks, and infections. The study explores advanced 3D scanning, computer-aided design, and 3D printing to customize these appliances for a better fit and fewer complications. Participants will first have their stoma scanned with a 3D scanner to create a detailed image, which is then edited and printed to produce a personalized ostomy template. This template and a modified commercial ostomy appliance, tailored to the patient's body and stoma, will be provided. The study includes two two-week periods: one using the participant's usual ostomy appliance, followed by two weeks using the personalized appliance created with 3D printing technology. During the study, participants will complete daily symptom diaries and weekly quality of life surveys conducted by phone over four weeks. Researchers will monitor leakage rates and other outcomes like skin irritation and overall comfort. The study requires participants to have internet access and the ability to complete electronic surveys and consent forms. The main outcome measured is the incidence of leaks over 28 days.
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
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Trial Site Locations
Total: 1 location
1
Carilion Clinic
Roanoke, Virginia, United States, 24013
Actively Recruiting
Research Team
A
Adam Goode, MD
U
Uma Kelavkar
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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