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New treatment option for 3D Printing
Official title 3D Printed Personalized Ostomy Appliance
ClinicalTrials.gov ID: NCT06310070
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join 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.
- Diagnosis of infection around the peristomal region. (erythema is NOT an exclusion criteria)
The study team makes the final eligibility decision.
Where it's taking place
- Roanoke, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roanoke, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.