Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310070
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-07
Brief Title:
3D Printed Personalized Ostomy Appliance
Sponsor:
Carilion Clinic
Organization:
Carilion Clinic
Study Overview
Official Title:
3D Printed Personalized Ostomy Appliance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3DPPOA
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
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 patients 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 patients 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
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 patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None