Clinical trials: Ileostomy
Ileostomy
A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy
Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing.
- Trial name
- U366 (NCT01782196)
- Testing
- Enhanced one piece drainable pouch with Type A mouldable adhesive, Enhanced one piece drainable pouch with Type B mouldable adhesive
- Where
- 5 sites in United Kingdom
- Volunteers
- 13 people
- Sponsor
- ConvaTec Inc.
Obesity, Type 2 Diabetes
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico
The purpose of this clinical research study is to evaluate the feasibility / performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI…
- Trial name
- NCT07085741
- Testing
- MAGNET System, DI Biofragmentable
- Where
- Mexico
- Volunteers
- 10 people
- Sponsor
- GT Metabolic Solutions, Inc.
Healthy Volunteers
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.
- Trial name
- NCT02419001
- Testing
- Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC, Period 2 - Treatment Sequence AB
- Where
- 3 sites in United States, Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Theriva Biologics, Inc.
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
Rectal Cancer, Ulcerative Colitis
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement…
- Conditions
- Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis
- Trial name
- NCT00663819
- Testing
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement, Staple line without reinforcement
- Where
- 16 sites in United States
- Volunteers
- 258 people
- Sponsor
- W.L.Gore & Associates
Ileostomy
One Piece Drainable Pouch in Subjects With an Ileostomy
To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.
- Trial name
- NCT01939106
- Testing
- One Piece Drainable Pouch
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- ConvaTec Inc.
Short Bowel Syndrome, Short Gut Syndrome
A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals
MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the symptoms of Short Bowel Syndrome and reduce the…
- Conditions
- Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Bowel
- Trial name
- NCT02242656
- Testing
- Opium Tincture USP Deodorized
- Where
- 5 sites in United States
- Sponsor
- Marathon Pharmaceuticals, LLC
Ileostomy
An Investigation of Ostomy Devices
Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.
- Trial name
- NCT01514136
- Testing
- Ostomy appliance: convex 1-piece drainable
- Where
- Denmark
- Volunteers
- 32 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
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
Peristomal Skin Complication
Preliminary Evaluation of CASTLE Barrier North American Prototype
The purpose of this study is to determine if an ostomy barrier that promotes a healthy skin environment will result in reduced peristomal skin irritation.
- Trial name
- NCT01413672
- Testing
- Use of CASTLE barrier
- Where
- 5 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Hollister Incorporated
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
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
Short Bowel Syndrome, Short Gut Syndrome
A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
MP-101 will be evaluated in this study to see if it is safe and tolerable.
- Conditions
- Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Gut
- Trial name
- NCT02246816
- Testing
- 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
- Where
- 5 sites in United States
- Sponsor
- Marathon Pharmaceuticals, LLC
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
Ileostomy, Colostomy
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
- Trial name
- NCT02362360
- Testing
- Coloplast Test Product, Comparator (Hollister)
- Where
- 5 sites in Denmark, Germany and 2 more
- Volunteers
- 52 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.
Retraction of Colostomy
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total…
- Trial name
- IMPROVE-IR (NCT01509638)
- Testing
- Group 1 Standard of Care, Group 2 EXPAREL
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- Pacira Pharmaceuticals, 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