Clinical trials: Stoma Ileostomy
Enterostomy, Stoma Ileostomy
Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
The study is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice and according to Instructions…
- Conditions
- Enterostomy, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT05373888
- Testing
- Flexima®/Softima® stoma bags
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- BBraun Medical SAS
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
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
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 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
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
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
Colostomy Stoma, Ileostomy - Stoma
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test…
- Trial name
- OUTFLOW (NCT06394115)
- Testing
- Ostomy pouch
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- ConvaTec Inc.
Colorectal Surgery, Colorectal Cancer
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an…
- Conditions
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma
- Trial name
- COLO-BT (NCT05826743)
- Testing
- COLO BT™, Stoma Creation
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- JSR Medical Co., Ltd.
Ileostomy - Stoma
A New Method for Ileostomy Output Collection Using an Intestinal Tampon
The goal of this interventional study is to learn if a specialized absorbent intestinal tampon can effectively collect ileostomy output.
- Trial name
- NCT06897163
- Testing
- Specialized Absorbent Intestinal Tampon
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Ampa Medical
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
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
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
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.
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
Crohn's Disease
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
The purpose of this study is to evaluate safety, tolerability, and effect on mucosal repair of AZD7798 compared with placebo in participants with active ileal Crohn's disease and an ileostomy.
- Trial name
- CALLISTO (NCT06681324)
- Testing
- AZD7798
- Where
- 17 sites in Belgium, Italy and 5 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Ileostomy - Stoma
Evaluation of the Influence of Output on Skin Covered by Newly Developed Adhesives
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive.
- Trial name
- NCT02886455
- Testing
- Standard adhesive strip, New adhesive strip
- Where
- Denmark
- Volunteers
- 4 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
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