Clinical trials: Stoma Ileostomy
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.
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
Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
To investigate the performance and safety of the three 2-piece convex ostomy appliances
- Trial name
- NCT01957397
- Testing
- Coloplast Test 1, Coloplast Test 2, Coloplast Test 3
- Where
- Denmark
- Volunteers
- 26 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
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
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
Stoma Ileostomy
Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy
The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.
- Trial name
- CP257 (NCT02887144)
- Testing
- SenSura, SenSura test product
- Where
- Denmark
- Volunteers
- 72 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
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
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
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device
This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated. The investigational device is SenSura® Mio Kids, which is a flat ostomy device.
- Trial name
- NCT03784989
- Where
- United States
- Volunteers
- healthy volunteers welcome
- 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
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
Ileostomy - Stoma
Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
- Trial name
- NCT03416023
- Testing
- TIES® (Transcutaneous Implant Evacuation System)
- Where
- 4 sites in Sweden, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Ostomycure AB
Ileostomy - Stoma
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
- Trial name
- NCT01799239
- Testing
- Test product, SenSura
- Where
- Sweden
- Volunteers
- 32 people
- Sponsor
- Coloplast A/S
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
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.
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
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
Stoma Ileostomy
Investigation of a Supporting Ostomy Product Intended for Leakage Detection
People with intestinal stomas (especially an ileostomy) can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
- Trial name
- NCT04894084
- Testing
- CP321
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Coloplast A/S