RECRUITING

3D Printed Personalized Ostomy Appliance

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

3D Printed Personalized Ostomy Appliance

Quick Facts

Study Start:2024-05-10
Study Completion:2025-06-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06310070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-100 years old
  2. * 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.
  3. * 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.
  4. * Participants must be able to consent for themselves
  5. * Access to phone AND computer with internet access. Patient must be able to provide electronic mailing address for e-consent documentation and REDCap surveys.
  1. * Concern for patient being able to be reached over the phone or reliable internet access for REDCap survey completion
  2. * Existing peri-stomal skin breakdown including ulceration or mucocutaneous separation.
  3. * Diagnosis of infection around the peristomal region. (erythema is NOT an exclusion criteria)

Contacts and Locations

Study Contact

Adam Goode, MD
CONTACT
540-224-5170
aegoode@carilionclinic.org
Uma Kelavkar
CONTACT
ukelavkar@carilionclinic.org

Principal Investigator

Farrell Adkins, MD
PRINCIPAL_INVESTIGATOR
Carilion Clinic

Study Locations (Sites)

Carilion Clinic
Roanoke, Virginia, 24013
United States

Collaborators and Investigators

Sponsor: Carilion Clinic

  • Farrell Adkins, MD, PRINCIPAL_INVESTIGATOR, Carilion Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-10
Study Completion Date2025-06-05

Study Record Updates

Study Start Date2024-05-10
Study Completion Date2025-06-05

Terms related to this study

Additional Relevant MeSH Terms

  • 3D Printing
  • Ostomy
  • Leakage