Clinical trials: Ileostomy - Stoma
Colorectal Neoplasms, Stoma Colostomy
Digital Based Home Care Service for Ostomy Patients
This study aims to enhance the physical, psychological, and social aspects of stoma care by providing a self-management service via a smartphone application, and to evaluate the impact of this digital-based application on…
- Conditions
- Colorectal Neoplasms, Stoma Colostomy, Stoma Ileostomy
- Trial name
- NCT06540430
- Testing
- The Use of a Mobile Application for Stoma Self-Care
- Volunteers
- 120 people
- Sponsor
- Wonju Severance Christian Hospital
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
Stoma Colostomy, Stoma Ileostomy
The Impact of Education Using a Stoma Care Training Belt
Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and…
- Trial name
- NCT06391398
- Testing
- Stoma care education with the Stoma Care Training Belt
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 170 people
- Sponsor
- Ankara University
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
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
Colitis Ulcerosa, Colitis Ulcerative
Magnesium in Gastrointestinal Disease
Individuals with gastrointestinal diseases - such as Crohn's disease, ulcerative colitis, ileostomy, or bile acid diarrhoea - are at increased risk of magnesium deficiency.
- Conditions
- Colitis Ulcerosa, Colitis Ulcerative, Crohns Disease, Morbus Crohn
- Trial name
- MAGIC (NCT07338565)
- Where
- Denmark
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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.
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, 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
Assessment of the Effect of Output on New Adhesives
The study investigates the impact real output has on adhesion of new adhesives
- Trial name
- NCT03331783
- Testing
- Standard hydrocolloid adhesive patch, LT-2, LT-21
- Where
- Denmark
- Volunteers
- 5 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy, Stoma Colostomy
The Effect of Stoma Care Education on the Knowledge and Skill Levels of Pediatric Surgery Nurses
This project; It is a quasi-experimental prospective study in a single group pre-test post-test order. No randomization will be made in the selection of the sample, and 30 nurses working in the Pediatric Surgery Clinic in…
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Nurse's Role, Pediatric Surgery
- Trial name
- NCT04984161
- Testing
- education
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Izmir Katip Celebi University
Rectal Neoplasms, Low Anterior Resection
Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer
Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing low anterior resections(LAR).
- Trial name
- CTI (NCT02012023)
- Testing
- Low anterior resection, tube ileostomy, loop ileostomy
- Where
- China
- Volunteers
- 80 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
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
Rectal Neoplasm
Loop Ileostomy Closure:Stapled or Hand-sewn Anastomoses? Suture or Mesh Closure of the Stoma Site?
There are severel problems associated with the closing of a temporary loop-ileostomy after surgery for rectal cancer. The purpose of this study is to answer two questions: 1.
- Trial name
- LISTO (NCT02669992)
- Testing
- Stapled or Hand-sewn anastomosis, Mesh or suture stoma site closure
- Where
- 11 sites in Sweden
- Volunteers
- 400 people
- Sponsor
- Karolinska University Hospital
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
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
Incisional Hernia, Ileostomy - Stoma
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure
Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak.
- Trial name
- NCT06511414
- Testing
- duramesh, Control
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Northwestern University