Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
NCT06310070

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

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Carilion Clinic

Roanoke, Virginia, United States, 24013

Actively Recruiting

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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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