Clinical trials: Stoma - Ileostomy
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
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, 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
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.
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
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.
Stoma Ileostomy
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device
This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated. The investigational device is SenSura® Mio Kids, which is a flat ostomy device.
- Trial name
- NCT03784989
- Where
- United States
- Volunteers
- 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
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, Stoma Colostomy
Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Quality of Life
- Trial name
- StomaCare (NCT05076669)
- Testing
- stoma follow-up, standard of care
- Where
- 10 sites in France
- Volunteers
- 350 people
- Sponsor
- FSK
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
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
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
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, Ileostomy; Complications
Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study
In this study 100 patients due to undergo surgery that will result in an ostomy will be provided with the Alfred SmartBag system.
- Trial name
- NCT03982875
- Testing
- Alfred SmartBag
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- 11 Heath and Technologies Limited
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
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
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
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
Assessement of the Peal Force Needed to Peel New Adhesives From the Skin
This study investigates the adhesion of new adhesives to the skin.
- Trial name
- NCT03289013
- Testing
- Standard adhesive 1, Standard adhesive 2, LT-2
- Where
- Denmark
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S