Clinical trials: Stoma Colostomy
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 Colostomy
Performance Study of Newly Developed Ostomy Products
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies.
- Trial name
- NCT01513330
- Testing
- SenSura Mio, Standard Care
- Where
- Germany
- Volunteers
- 122 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
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.
Colostomy Stoma
Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients
The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment.
- Trial name
- NCT05466721
- Testing
- Hydrustoma C3, Coloplast Alterna
- Where
- 6 sites in Portugal
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Hydrumedical
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
Colostomy Stoma
Human Skin Test Model in Colostomists
The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin…
- Trial name
- NCT01918085
- Testing
- Hydrocolloid strip, Strata strip
- Volunteers
- 22 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
Colostomy
One Piece Closed Pouch in Subjects With a Colostomy
A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
- Trial name
- NCT01935999
- Testing
- One piece closed pouch
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- ConvaTec Inc.
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
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
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
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
Diverticulum, Colon, Colorectal Neoplasms
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
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 a single center.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- RETROPRESS (NCT01301417)
- Testing
- ColonRing™
- Where
- United States
- Volunteers
- 171 people
- Sponsor
- novoGI
Colostomy Stoma
Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
- Trial name
- NCT03108105
- Testing
- AOS-C2001-B
- Where
- France
- Volunteers
- 30 people
- Sponsor
- BBraun Medical SAS
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
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
Colostomy - Stoma, Colostomy Complications
Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication
This 3-way crossover study aims to evaluate whether colostomy bags with an active chamber filter system reduce the incidence of filter-related complications, such as ballooning and pancaking, help neutralise odour, and minimise…
- Trial name
- BREEZE-01 (NCT06739174)
- Testing
- Confidence Be 1-Piece Closed Bag, Confidence Natural 1-Piece Closed Bag, Confidence Be go 1-Piece Closed Bag
- Where
- United Kingdom
- Volunteers
- 27 people
- Sponsor
- Salts Healthcare
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