3D Printed Personalized Ostomy Appliance

NCT06310070 | Recruiting FDA Device

• 1 other identifier: IRB-23-1965
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Leaks

  Number of leaks experienced on a daily basis by participant

  28 days

Secondary Outcomes (2)

• Number of appliances

  28 days

• Overall patient satisfaction

  28 days

Study Arms (1)

Receiving 3D Personalized Ostomy Appliance

EXPERIMENTAL

The personalized ostomy appliances are designed based off of a 3D scan. We will scan your ostomy to create a 3D picture in the computer system that is an exact copy of your ostomy using plastic. We then apply computer aided design (CAD) tools to modify your normal ostomy baseplates.

Device: 3D Printed Personalized Ostomy Appliance

Interventions

3D Printed Personalized Ostomy Appliance DEVICE

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.

Receiving 3D Personalized Ostomy Appliance

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24013, United States

RECRUITING

Study Officials

• Farrell Adkins, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Goode, MD

CONTACT

540-224-5170; aegoode@carilionclinic.org

Uma Kelavkar

CONTACT

ukelavkar@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: May 10, 2024
• Primary Completion: March 5, 2025
• Study Completion: June 5, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

US (1)