Clinical trials: Stoma
Healthy
Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin
Aim The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma.
- Trial name
- NCT01245413
- Testing
- SenSura, Athena
- Where
- Denmark
- Volunteers
- 32 people, healthy volunteers welcome
- 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
Stoma Ileostomy
CP376 OCT Exploratory Skin Study
An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled.
- Trial name
- NCT06965140
- Testing
- flat 1-piece open ostomy device
- Where
- Denmark
- Volunteers
- 12 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
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
Stoma Ileostomy
Evaluation of a New Supporting Ostomy Product
The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their…
- Trial name
- NCT04374890
- Testing
- CP308
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Evaluation of the Performance of a New Adhesive Strip
This study investigates the performance of a new adhesive strip when impacted by output.
- Trial name
- NCT03257787
- Testing
- new adhesive strip
- Where
- Denmark
- Volunteers
- 6 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
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas.
- Trial name
- NCT06554015
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigating the Adhesion of New Adhesive to the Skin
The adhesion of the new adhesive strips is investigated on healthy volunteers
- Trial name
- NCT03439176
- Testing
- Standard adhesive 1, Standard adhesive 2, PL4
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- 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
Colostomy - Stoma, Ileostomy - Stoma
Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
The purpose of this exploratory study is to obtain preliminary data on peristomal and non-peristomal skin barrier characterisation in people living with a stoma.
- Conditions
- Colostomy - Stoma, Ileostomy - Stoma, Urostomy
- Trial name
- Stoma Imprint (NCT07719309)
- Where
- United Kingdom
- Volunteers
- 108 people
- Sponsor
- Salts Healthcare
Stoma Ileostomy
Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.
Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively.
- Trial name
- NCT07316530
- Testing
- CP381
- Where
- Denmark
- Volunteers
- 13 people
- Sponsor
- Coloplast A/S
Surgical Stomas
Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma
Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2-piece coupling system with SenSura Mio Click.
- Trial name
- CP343 (NCT05652010)
- Testing
- New 2-piece Coupling, SenSura Mio Click
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Coloplast A/S