Clinical trials: Ileostomy - Stoma
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
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
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
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
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
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
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
Intestinal Failure, Enterocutaneous Fistula
Chyme Reinfusion for Type 2 Intestinal Failure
This project aims to introduce and evaluate a novel assistive prosthetic system that helps prevent and treat nutrient and fluid loss from enterocutaneous fistulas.
- Conditions
- Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma, High Output Stoma
- Trial name
- REINFUSE (NCT04577456)
- Testing
- The Insides System
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 44 people
- Sponsor
- The Insides Company
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
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, 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
Ileostomy - Stoma
Evaluation of the Influence of Output on Skin Covered by Adhesives
The study investigates the impact real output has on peristomal skin covered by two different adhesives
- Trial name
- NCT03000881
- Testing
- standard adhesive, New adhesive strip
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
CP376 OCT Exploratory Skin Study
An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled.
- Trial name
- NCT06965140
- Testing
- flat 1-piece open ostomy device
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Evaluation of the Effect of Output on New Adhesives
The study investigates the impanct real output has on the adhesion of a new adhesive
- Trial name
- NCT03257774
- Testing
- Adhesive strip A, Adhesive strip B, Adhesive strip C
- Where
- Denmark
- Volunteers
- 6 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
Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances
- Trial name
- NCT01994876
- Testing
- Coloplast Test 1, Coloplast Test 2
- Where
- Netherlands
- Volunteers
- 18 people
- Sponsor
- Coloplast A/S
Colorectal Cancer, Stoma - Ileostomy
SafeHeal Colovac Anastomosis Protection Device Evaluation Pivotal Study
Colorectal cancer is the third most common malignancy worldwide and the second most common in the US. It is the second leading cause of cancer death worldwide, with 1.8 million new cases and 862,000 deaths per year.
- Trial name
- SAFE-3CV (NCT07116668)
- Testing
- Colovac Anastomosis Protection Device placement following low anterior resection of colon cancer
- Where
- 18 sites in United States, Belgium and 2 more
- Volunteers
- 108 people
- Sponsor
- SafeHeal Inc
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
Ileostomy - Stoma
Evaluation of the Performance of an Adhesive Strip
This study investigated the performance of a new adhesive strip when impacted by output
- Trial name
- NCT03419013
- Testing
- New adhesive strip
- Where
- Denmark
- Volunteers
- 7 people
- Sponsor
- Coloplast A/S