Clinical trials: Ileostomy - Stoma
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
Stoma - Ileostomy
Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances
- Trial name
- NCT01957475
- Testing
- Coloplast Test product Y, Coloplast Test product Z
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
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
Stoma Site Leakage, Quality of Life
The Nordic Consensus Study
A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.
- Conditions
- Stoma Site Leakage, Quality of Life, Nurse's Role, Stoma Ileostomy
- Trial name
- NCS (NCT04763863)
- Testing
- Body Assessment Tool, Clinical usability evaluation of the Body Assessment Tool
- Where
- Denmark
- Volunteers
- 121 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Evaluation of the Peel Force of New Adhesives From the Skin
This study investigates the impact and adhesion of new adhesives to the skin.
- Trial name
- NCT03200444
- Testing
- Standard adhesive 1, Standard adhesive 2, Standard adhesive 3
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
- Trial name
- NCT01957384
- Testing
- Coloplast Test product 1, Coloplast Test product 2, Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products
- Trial name
- NCT01957488
- Testing
- Coloplast Test Product 1, Coloplast Test Product 2, Coloplast SenSura
- Where
- 4 sites in Denmark, Netherlands and 2 more
- Volunteers
- 183 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Safety and Performance of New 1-piece Ostomy Product
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
- Trial name
- NCT01800916
- Testing
- Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B, Coloplast Adhesive baseplate C
- Where
- Denmark
- Volunteers
- 65 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.
- Trial name
- NCT03619226
- Testing
- test patch
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Peristomal Skin Complication
Preliminary Evaluation of CASTLE Barrier Prototype UK
The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.
- Trial name
- NCT01530087
- Testing
- CASTLE barrier
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Hollister Incorporated
Ileostomy - Stoma, Colostomy
A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
- Trial name
- NCT02517541
- Testing
- SenSura Mio Convex Soft
- Where
- 9 sites in United States, Netherlands and 2 more
- Volunteers
- 74 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
The aim of the current clinical investigation is to evaluate a new filter
- Trial name
- NCT01272869
- Testing
- SenSura, Morfeus
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
To investigate the performance and safety of the three 2-piece convex ostomy appliances
- Trial name
- NCT01957397
- Testing
- Coloplast Test 1, Coloplast Test 2, Coloplast Test 3
- Where
- Denmark
- Volunteers
- 26 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
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
Ileostomy - Stoma
Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
- Trial name
- NCT03416023
- Testing
- TIES® (Transcutaneous Implant Evacuation System)
- Where
- 4 sites in Sweden, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Ostomycure AB
Ileostomy - Stoma
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
- Trial name
- NCT01799239
- Testing
- Test product, SenSura
- Where
- Sweden
- Volunteers
- 32 people
- Sponsor
- Coloplast A/S
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
A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.
- Trial name
- NCT03154944
- Testing
- Ostomy device 1, Ostomy device 2, Ostomy device 3
- Where
- Denmark
- Volunteers
- 38 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Investigation of a Supporting Ostomy Product Intended for Leakage Detection
People with intestinal stomas (especially an ileostomy) can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
- Trial name
- NCT04894084
- Testing
- CP321
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Coloplast A/S