Clinical trials: Ostomy
Ileostomy, Colostomy
Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.
- Trial name
- NCT02675634
- Testing
- Coloplast Test A, Coloplast Test B, Subjects own product
- Where
- 12 sites in United States, Denmark and 2 more
- Volunteers
- 55 people
- Sponsor
- Coloplast A/S
Stoma Colostomy
Performance Study of Newly Developed Ostomy Products
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies.
- Trial name
- NCT01513330
- Testing
- SenSura Mio, Standard Care
- Where
- Germany
- Volunteers
- 122 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
The aim of the investigation was to investigate the performance and safety of a new ostomy product.
- Trial name
- NCT01994902
- Testing
- Coloplast test product, SenSura Convex Light
- Where
- 29 sites in Denmark, France and 3 more
- Volunteers
- 129 people
- Sponsor
- Coloplast A/S
Subjects With an Ileostomy
Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
- Trial name
- NCT01800890
- Testing
- Coloplast A, Coloplast B, Coloplast C
- Where
- Denmark
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
Dermatologic Complications
Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
This purpose of this study is to look at three commercially available ostomy barriers on peristomal (around the stoma) skin. Repeated barrier application and removal over years causes changes to the skin that the investigators…
- Trial name
- NCT02003404
- Testing
- Control Abdominal Skin, Peristomal Abdominal Skin
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Hollister Incorporated
Ostomy
The Advocate Study
Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.
- Trial name
- NCT02401412
- Testing
- Test Ostomy Barrier, Control Ostomy Barrier
- Where
- 12 sites in United States, Canada
- Volunteers
- 170 people
- Sponsor
- Hollister Incorporated
Ostomy
Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients
The making of an ostomy in patients is experienced as traumatic. The stoma changes body image, self-esteem and is responsible for increased anxiety. These changes affect the quality of life of patients.
- Trial name
- Stomie 3D (NCT04326335)
- Testing
- Felt-tip marking, Felt-tip marking + 3D printed ostomy button
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Departemental Vendee
Stoma Ileostomy, Stoma Colostomy
Investigation of a New 1-piece Convex Ostomy Product
The aim of the investigation was to investigate the performance and safety of a new ostomy product
- Trial name
- NCT02043782
- Testing
- Coloplast Test, Own product, Competitor soft convex
- Where
- Denmark
- Volunteers
- 38 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma, Colostomy Stoma
Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product
People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
- Trial name
- NCT05200416
- Testing
- Heylo, Standard of Care
- Where
- Germany
- Volunteers
- 144 people
- Sponsor
- Coloplast A/S
Colorectal Cancer, Bladder Cancer
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer…
- Conditions
- Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer
- Trial name
- PRISMS (NCT04492007)
- Testing
- Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Ileostomy
An Investigation of Ostomy Devices
Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.
- Trial name
- NCT01514136
- Testing
- Ostomy appliance: convex 1-piece drainable
- Where
- Denmark
- Volunteers
- 32 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
A Clinical Investigation Examining the Performance and Handling of New 2-piece Ostomy Products in 28 People With an Ileostomy.
To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.
- Trial name
- NCT02064231
- Testing
- Coloplast Test A, Coloplast Test B, Own product
- Volunteers
- 28 people
- Sponsor
- Coloplast A/S
Ostomy
Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™ Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to caustic body fluids from an ostomy, drain site…
- Trial name
- NCT03057132
- Testing
- Cavilon Advanced Skin Protectant
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Solventum US LLC
Parastomal Hernia
Parastomal Reinforcement With Strattice
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of…
- Trial name
- PriSm (NCT00771407)
- Testing
- Strattice Reconstructive Matrix, Standard ostomy creation
- Where
- 23 sites in United States
- Volunteers
- 120 people
- Sponsor
- LifeCell
Ileostomy, Colostomy
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
- Trial name
- NCT02362360
- Testing
- Coloplast Test Product, Comparator (Hollister)
- Where
- 5 sites in Denmark, Germany and 2 more
- Volunteers
- 52 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigation of the Performance of Ostomy Base Plate
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2.
- Trial name
- NCT01103466
- Testing
- Atlas, SenSura, Conform 2
- Where
- Denmark
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Anesthesia, Ostomy
Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery
The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.
- Trial name
- NCT01136668
- Testing
- Transversus Abdominis Plane Block, Standard
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- The Hospital for Sick Children
Colostomy Stoma
Ostomy Telehealth For Cancer Survivors
The purpose of this study is to test the benefits of an educational program, the Ostomy Self-Management Training (OSMT) program, for improving patient activation (preparedness to do self-care), self-efficacy (patients' ability to…
- Trial name
- PCORI (NCT02974634)
- Testing
- Ostomy self management training
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- University of Pennsylvania
Ostomy
Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
The purpose of this study is to evaluate patient satisfaction and quality of life in patients with ileostomy managed with or without the novel Ostom-i Alert device.
- Trial name
- NCT02472639
- Testing
- Ostom-i Alert Sensor, No Ostom-i Alert Sensor
- Volunteers
- 7 people
- Sponsor
- Cedars-Sinai Medical Center
Stoma Ileostomy, Stoma Colostomy
Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation
People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
- Trial name
- NCT05135754
- Testing
- Heylo
- Where
- 10 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Coloplast A/S