Clinical trials: Ileostomy
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
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
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
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
Obesity
Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System
This is an operationally seamless, open-label, multicenter study enrolling up to 50 subjects with obesity and with or without type 2 diabetes at up to 5 study centers across Canada and Europe who will undergo sleeve gastrectomy…
- Trial name
- NCT05322122
- Testing
- Side-to-side anastomosis duodeno-ileostomy diversion procedure
- Where
- 4 sites in Belgium, Canada and 2 more
- Volunteers
- 49 people
- Sponsor
- GT Metabolic Solutions, Inc.
Stoma Ileostomy
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
The aim of the investigation was to investigate the performance and safety of a new ostomy product.
- Trial name
- NCT01994902
- Testing
- Coloplast test product, SenSura Convex Light
- Where
- 29 sites in Denmark, France and 3 more
- Volunteers
- 129 people
- Sponsor
- Coloplast A/S
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
Leakage
A Clinical Investigation of New Ostomy Appliances
This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks.
- Trial name
- NCT01523756
- Testing
- test product 1: new ostomy base plate with Coloplast as manufacturer, test product 2: new ostomy base plate with Coloplast as manufacturer
- Where
- Denmark
- Volunteers
- 20 people
- 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
Stoma Ileostomy
Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.
- Trial name
- NCT03929978
- Volunteers
- healthy volunteers welcome
- 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.
Stoma - Ileostomy
Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances
- Trial name
- NCT01957475
- Testing
- Coloplast Test product Y, Coloplast Test product Z
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
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
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
Subjects With an Ileostomy
Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
- Trial name
- NCT01800890
- Testing
- Coloplast A, Coloplast B, Coloplast C
- Where
- Denmark
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
Retraction of Ileostomy
SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression
The objectives of this study are to determine the safety and effectiveness of the SFM Anastomosis Device when used to create a small bowel anastomosis for patients undergoing ileostomy reversal as compared with a…
- Trial name
- SEAM (NCT05046730)
- Testing
- Ileostomy Reversal using Self Forming Magnets (SFM)
- Where
- 14 sites in United States
- Volunteers
- 128 people
- Sponsor
- GI Windows, Inc.
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, Colostomy
Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.
- Trial name
- NCT02675634
- Testing
- Coloplast Test A, Coloplast Test B, Subjects own product
- Where
- 12 sites in United States, Denmark and 2 more
- Volunteers
- 55 people
- Sponsor
- Coloplast A/S
Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy
Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of INTERCEED™
This is a prospective, randomized controlled study. The study population will include 220 subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with preventive ileostomy (Phase 1 operation).
- Trial name
- NCT03462563
- Testing
- INTERCEED™
- Where
- 12 sites in China
- Volunteers
- 175 people
- Sponsor
- Ethicon, Inc.