Clinical trials: Stoma Ileostomy
Ileostomy - Stoma
Assessment of New Ostomy Devices in Subjects Having an Ileostomy
The study investigates the performance of three new adhesives with regard to leakage and the skin condition.
- Trial name
- NCT03427203
- Testing
- SenSura Mio, Coloplast Ostomy device 1, Coloplast Ostomy device
- Where
- 3 sites in Denmark, Netherlands
- Volunteers
- 35 people
- Sponsor
- Coloplast A/S
Diverticulum, Colon, Colorectal Neoplasms
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- NCT01880918
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- novoGI
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
Feasibility of a Newly Developed Ostomy Prototype
Despite the development of better stoma products, individuals with intestinal stomas can experience leakage problems, which negatively affect their quality of life.
- Trial name
- NCT07146035
- Testing
- CP369 Feasibility of a newly developed ostomy prototype (only one intervention)
- Where
- Denmark
- Volunteers
- 10 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
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
One Piece Drainable Pouch in Subjects With an Ileostomy
To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.
- Trial name
- NCT01939106
- Testing
- One Piece Drainable Pouch
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- ConvaTec Inc.
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, 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
Investigating the Performance of a New Adhesive Strip
This study investigates the performance of a new adhesive
- Trial name
- NCT03423134
- Testing
- New adhesive strip
- Where
- Denmark
- Volunteers
- 6 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
Evaluation of the Influence of Output on Skin Wearing a New Adhesive
The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.
- Trial name
- NCT03200431
- Testing
- New adhesive strip
- Where
- Denmark
- Volunteers
- 6 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
The Influence of Output on Skin Covered by Adhesive With Topfilm
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.
- Trial name
- NCT03044275
- Testing
- New adhesive strip, Standard adhesive strip
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Evaluation of the Influence of New Adhesives of Output on Skin
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive
- Trial name
- NCT03044262
- Testing
- Standard adhesive strip, New adhesive strip
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Assessment of the Performance of a New Ostomy Device in Subjects Having an Ileostomy
The purpose was to investigate the performance of a new ostomy device measured with a measuring device.
- Trial name
- NCT03439241
- Testing
- Coloplast ostomy device
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.
- Trial name
- NCT03929978
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Evaluation of the Influence of Output on a Newly Develop Adhesive
The study investigates the impact real output has on the adhesion of adhesives.
- Trial name
- NCT02886403
- Testing
- Standard adhesive strip, New adhesive strip
- Where
- Denmark
- Volunteers
- 5 people
- Sponsor
- Coloplast A/S
Inflammatory Bowel Diseases, Short Bowel Syndrome
Effects of an Amino Acid Mixture on Gastrointestinal Function, Inflammation and Fluid Balance: A Pilot Study in Patients With Inflammatory Bowel Disease
This pilot study will examine the benefit of this amino acid based hydration solution in patients with IBD who have undergone a total colectomy and have either ileostomies or jpouches.
- Conditions
- Inflammatory Bowel Diseases, Short Bowel Syndrome, Ileostomy - Stoma
- Trial name
- NCT03451253
- Testing
- amino acid mixture beverage, glucose-based sports drink
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Entrinsic Bioscience Inc.