3D Printing3DPPOANCT06310070
3D Printed Personalized Ostomy Appliance
A study testing 3D Printed Personalized Ostomy Appliance in people with 3D Printing and Ostomy, run by Carilion Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- 3D Printing, Ostomy, Leakage
- What is being tested?
- 3D Printed Personalized Ostomy Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2024to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uma Kelavkar contact
United States1 site, 1 recruiting
- Recruiting
Carilion Clinic
Roanoke, Virginia, 24013
Adam Goode, MD, aegoode@carilionclinic.org
About this study
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
Read the detailed 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.
- Conditions
- 3D Printing, Ostomy, Leakage
- Being tested
- 3D Printed Personalized Ostomy Appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Personalized Ostomy ApplianceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 3D Printed Personalized Ostomy Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Leaks
Number of leaks experienced on a daily basis by participant
Measured: 28 days
Secondary outcomes (2)
Number of appliances
Number of ostomy bag changes completed by participant
Measured: 28 days
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."
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start10 May 2024
- Primary completion5 Mar 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 3D PrintingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Sponsor
- Investigators
- Farrell Adkins, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310070
- Sponsor's protocol ID
- IRB-23-1965
- Acronym
- 3DPPOA
- Status last verified
- Jan 2025
- First submitted
- 7 Mar 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Personalized Ostomy Appliance
- ClinicalTrials.gov ID
- NCT06310070
- Acronym / sponsor ID
- 3DPPOA / IRB-23-1965
- Conditions
- 3D Printing, Ostomy, Leakage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 10 May 2024 (actual)
- Primary completion
- 5 Mar 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving 3D Personalized Ostomy Appliance | Experimental | Device: 3D Printed Personalized Ostomy ApplianceThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Printed Personalized Ostomy ApplianceStudy 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. | Device | Receiving 3D Personalized Ostomy Appliance |
Primary outcome
Incidence of Leaks
Time frame: 28 days
Number of leaks experienced on a daily basis by participant
2 secondary outcomes
Number of appliances
Time frame: 28 days
Overall patient satisfaction
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Uma Kelavkar contact
Farrell Adkins, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Printed Personalized Ostomy Appliance in people with 3D Printing and Ostomy, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Goode, MD (540-224-5170, aegoode@carilionclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Leaks (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.