3D Printed Personalized Ostomy Appliance

Ostomy Clinical Trial

— 3DPPOA  

Official title:

3D Printed Personalized Ostomy Appliance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310070
• Other study ID #: IRB-23-1965
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 5, 2025
• Est. completion date: June 5, 2025

Study information

• Verified date: March 2024
• Source: Carilion Clinic
• Contact: Adam Goode, MD
• Phone: 540-224-5170
• Email: aegoode[@]carilionclinic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Formation of an ostomy is an operation that connects a hollow viscus, such as the bowel, to the skin. An ostomy appliance is worn to collect waste around the stoma, the externalized viscus organ. Ostomy appliances are emptied several times a day and are exchanged as infrequently as once per week or as frequently as multiple times per day. Unfortunately, half of all patients with an ostomy will suffer from complications such as peristomal skin breakdown, skin irritation, leaks, and bleeding. Stoma measuring guides are used to measure the ostomy appliance to achieve a well-fit skin barrier and prevent peristomal skin complications. Leaks both dramatically decrease patients' quality of life and result in skin irritation and other complications including infections.

Investigators propose utilizing advances in 3D scanning, computer-aided design (CAD) modeling, and 3D manufacturing to create a personalized ostomy appliance.

Site investigators will develop a 3D personalized ostomy appliance protocol featuring three phases: first, the patient's stoma is scanned using a 3D scanner in CRSudio2; second, the raw scan is edited using personalized variables to create a filtered mesh; third, the filtered mesh is printed to provide an ostomy template to the patient and currently available ostomy appliances are modified using a laser cutter to provide a personalized ostomy appliance to the patient. The selection of commercially available ostomy appliance will be done in coordination with the ostomy nursing team. Based upon the patient's body habitus and stoma, the ostomy nurse will select the recommended appliance that is available at Carilion Clinic. This will be the appliance that is customized using the laser cutter.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 5, 2025
• Est. primary completion date: March 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Leakage
• Ostomy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Carilion Clinic	Virginia Polytechnic Institute and State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Leaks	Number of leaks experienced on a daily basis by participant	28 days
Secondary	Number of appliances	Number of ostomy bag changes completed by participant	28 days
Secondary	Overall patient satisfaction	Ostomy Leak Appliance Tool Survey will ask participants to answer questions related to their experiences of leaking within the previous 7 days, including information on the frequency of leakage and emotional impact of how a leak or risk of leakage affected how the participant felt. Participants will answer how they felt, whether they were able to complete usual day to day activities and how they coped by answering on a scale of "All of the time," "Often," "Sometimes," or "Rarely or never."	28 days