Clinical trials: Ileostomy
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
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.
Ostomy, Ileostomy - Stoma
CP384 - Ostomy Care (OC) PRO Panel Plan
The aim is to create an electronic patient reported outcome (e-PRO) based registry, specifically for subjects living with a stoma (ileostomy, colostomy or urostomy).
- Conditions
- Ostomy, Ileostomy - Stoma, Urostomy
- Trial name
- 384 PRO Panel (NCT07589907)
- Volunteers
- 1,000 people
- Sponsor
- Coloplast A/S
Colorectal Cancer, Stoma Ileostomy
SafeHeal Diverting Ileostomy Pivotal Study
This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications.
- Trial name
- SH-SOC23 (NCT06152276)
- Testing
- Diverting loop ileostomy
- Where
- 22 sites in United States, Belgium and 2 more
- Volunteers
- 132 people
- Sponsor
- SafeHeal 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
- NCT07376421
- Testing
- Incestigational device, Comparator
- Where
- Denmark
- Volunteers
- 20 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
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, Colostomy
SCOPE - Single-Point Classification Observational Peristomal Evaluation
Study to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment.
- Conditions
- Ileostomy, Colostomy, Urostomy
- Trial name
- NCT06614491
- Where
- 4 sites in Brazil, Colombia
- Volunteers
- 605 people
- Sponsor
- ConvaTec Inc.
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
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
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma
This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas.
- Trial name
- NCT06554015
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)
This study investigates the impact real output has on peristomal skin covered by an adhesive
- Trial name
- NCT02992444
- Testing
- Standard adhesive strip, Experimental adhesive strip
- Where
- Denmark
- Volunteers
- 5 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
Ileostomy
A Pilot Evaluation of Adhesives and How They Are Impacted by Output (Round 1b)
The study investigates the impact real output has on the adhesion of adhesives.
- Trial name
- NCT02626260
- Testing
- adhesive strip
- Where
- Denmark
- Volunteers
- 4 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
Stoma Ileostomy
Clinical Investigation Exploring Two Ostomy Product Prototypes
Two ostomy product prototypes (Test product A and B) will be tested in this investigation. All subjects will test both Test product A and B, with a minimum of 7 days apart.
- Trial name
- NCT06237686
- Testing
- CP363
- Where
- Denmark
- Volunteers
- 11 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
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, 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
A Clinical Investigation Evaluating Three New 1-piece Ostomy Products
This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.
- Trial name
- NCT03154944
- Testing
- Ostomy device 1, Ostomy device 2, Ostomy device 3
- Where
- Denmark
- Volunteers
- 38 people
- Sponsor
- Coloplast A/S