Actively Recruiting
3D Printed Personalized Ostomy Appliance to Reduce Leakages and Improve Quality of Life
Led by Carilion Clinic · Updated on 2025-01-22
30
Participants Needed
1
Research Sites
13 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 the effectiveness of using a 3D scan to create personalized ostomy appliances for people with an ostomy. The study focuses on whether a 3D scan of the stoma can reduce leakages and improve quality of life compared to standard care. Ostomy appliances collect waste from the stoma but often cause complications such as skin irritation, leaks, and infections, which impact patients' daily lives. Participants will have their stoma scanned with a 3D scanner to create a detailed digital model. This model is then edited and used to produce a personalized ostomy appliance by modifying standard appliances with a laser cutter. The study involves two 2-week periods where participants use their usual ostomy appliance first, then the personalized 3D-printed appliance. The personalized appliances are designed with input from an ostomy nursing team to ensure proper fit based on each patient's body and stoma. During the 4-week study, participants will complete daily symptom diaries and weekly quality of life surveys conducted over the phone. Researchers will track leak incidents, the number of appliances used, and overall patient satisfaction. The study includes ongoing monitoring through electronic surveys requiring internet and device access. Total participation lasts about one month, with safety and quality of life as key measures.
CONDITIONS
Brief Title
3D Printed Personalized Ostomy Appliance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 100 years
- Must have used current ostomy appliance for more than 6 weeks
- Must have had more than one leakage in the week before consent
- Able to consent for themselves
- Access to a phone and a computer with internet to complete surveys and e-consent
You will not qualify if you...
- Unreliable phone or internet access for survey completion
- Existing peri-stomal skin breakdown including ulceration or mucocutaneous separation
- Infection diagnosis around the peristomal region (except erythema)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants have their stoma scanned using a 3D scanner. A personalized ostomy appliance is created using 3D printing and computer-aided design, then provided to the participant. Participants complete a daily symptom diary and a weekly survey for 4 weeks.
1 initial visit for scanning and appliance fitting; weekly surveys and daily symptom diary for 4 weeks
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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