Clinical trials: Ileostomy - Stoma
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
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
Ileostomy - Stoma, Colostomy Stoma
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
The study investigates the performance of a new adhesive with regard to the skin condition
- Trial name
- NCT03770078
- Testing
- Test Product A
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 23 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
Ileostomy - Stoma
Transversus Abdominis Plane Blocks for Ileostomy Takedown: A Prospective Study
Consenting subjects will be randomized to receive injection of bupivacaine or placebo before surgery for ileostomy takedown (injection administered after general anesthesia has been administered).
- Trial name
- NCT01411917
- Testing
- Transversus abdominis plane block
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- University of Wisconsin, Madison
Ileostomy - Stoma, Colostomy - Stoma
Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.
- Trial name
- NCT01957462
- Testing
- Coloplast Test V, Coloplast Test X
- Where
- Denmark
- Volunteers
- 31 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
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
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
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
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
The Influence of Baseplate Adhesive on the Degree of Leakage
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
- Trial name
- NCT01995357
- Testing
- Coloplast Test A, Coloplast Test B, Standard product
- Where
- Denmark
- Volunteers
- 22 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
Ileostomy - Stoma
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
- Trial name
- NCT01957553
- Testing
- Coloplast test product, SenSura
- Where
- 17 sites in Belgium, Denmark and 3 more
- Volunteers
- 130 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
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
Colon Cancer, Rectal Cancer
Stoma Closure and Reinforcement Trial
Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of…
- Conditions
- Colon Cancer, Rectal Cancer, Ileostomy - Stoma
- Trial name
- SCAR (NCT03750461)
- Testing
- Mesh Implantation
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Stoma Ileostomy
Clinical Investigation Exploring Two Ostomy Product Prototypes
Two ostomy product prototypes (Test product A and B) will be tested in this investigation. All subjects will test both Test product A and B, with a minimum of 7 days apart.
- Trial name
- NCT06237686
- Testing
- CP363
- Where
- Denmark
- Volunteers
- 11 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
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