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3D Printed Personalized Ostomy Appliance

Carilion Clinic · with Virginia Polytechnic Institute and State University · NCT06310070

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–100 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
1
Study start
May 10, 2024
Record last updated
January 22, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: 3D Printed Personalized Ostomy Appliance

Conditions: 3D Printing; Ostomy; Leakage

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 18-100 years old
  • 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.
  • 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.
  • Participants must be able to consent for themselves
  • Access to phone AND computer with internet access. Patient must be able to provide electronic mailing address for e-consent documentation and REDCap surveys.

Exclusion Criteria

  • Concern for patient being able to be reached over the phone or reliable internet access for REDCap survey completion
  • Existing peri-stomal skin breakdown including ulceration or mucocutaneous separation.
  • Diagnosis of infection around the peristomal region. (erythema is NOT an exclusion criteria)

Recruiting US locations

  • Carilion Clinic

    Roanoke, VA 24013

    Site contact: Adam Goode, MD · aegoode@carilionclinic.org

Study contacts (from the official record)

  • Adam Goode, MD · 540-224-5170 · aegoode@carilionclinic.org
  • Uma Kelavkar · ukelavkar@carilionclinic.org
All healthy volunteers studies in Virginia →
3D Printed Personalized Ostomy Appliance (NCT06310070) | Bored Studies