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3D Printed Personalized Ostomy Appliance

NCT06310070 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-22

No results posted yet for this study

Summary

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

  • 3D Printing
  • Ostomy
  • Leakage

Interventions

DEVICE

3D Printed Personalized Ostomy Appliance

Study procedures will include getting your stoma scanned, receiving personalized ostomy appliances in the mail, receiving a personalized ostomy template, which will be printed using a 3D printer, in the mail, and completing a daily symptom diary along with a weekly survey for 4 weeks.3D printing is done using a machine that takes the 3D image from the computer and prints a replica of the image using plastic or other materials.

Sponsors & Collaborators

  • Virginia Polytechnic Institute and State University

    collaborator OTHER

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • Farrell Adkins, MD · Carilion Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2025-03-05
Completion
2025-06-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06310070 on ClinicalTrials.gov