Leakage Clinical Trial - 3D Printed Personalized Ostomy Appliance

Status Not yet recruiting

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06310070
Study type	Interventional
Source	Carilion Clinic
Contact	Adam Goode, MD
Phone	540-224-5170
Email	aegoode@carilionclinic.org
Status	Not yet recruiting
Phase	N/A
Start date	March 5, 2025
Completion date	June 5, 2025

View Details

See also
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Active, not recruiting	`NCT00391508` - Skin Problems in Ostomy Patients: An Epidemiological Study	N/A
Recruiting	`NCT04943822` - The Effectiveness of APP Intervention on Home Self-care Ability and Quality of Life of Patients With Intestinal Stoma	N/A
Recruiting	`NCT03715179` - Observational Study of Ostomy Consumers
Terminated	`NCT03057132` - Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula	N/A
Recruiting	`NCT02319434` - Ostom-i Alert Sensor Quality of Life Validation
Terminated	`NCT02036268` - Different Levels of Patient Education for Care of Ostomy Site	N/A
Completed	`NCT02401412` - The Advocate Study	N/A
Active, not recruiting	`NCT05745909` - Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy	N/A
Completed	`NCT02889536` - Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences	N/A
Recruiting	`NCT05796544` - Effectiveness of Remote Self-care Education for Ostomy Patients	N/A
Completed	`NCT05573256` - Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life	N/A
Terminated	`NCT02472639` - Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy	N/A
Recruiting	`NCT04326335` - Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients	N/A
Unknown status	`NCT01526967` - Observational Evaluation of the Peristomal Skin Condition in Ostomates	N/A
Completed	`NCT04635215` - Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology
Recruiting	`NCT06213441` - Improving the Quality of Life and Self-sufficiency of Individuals With Stoma: Pecha Kucha Training Via Smartphone	N/A
Completed	`NCT01261988` - Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™	Phase 1
Completed	`NCT04561674` - The Effect of Web-Based Patient Education on Quality of Life of Patients With Colostomy and Ileostomy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

3D Printed Personalized Ostomy Appliance — 3DPPOA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms