Clinical trials: Stoma
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
Ileostomy - Stoma
Assessment of the Performance of a New Ostomy Device in Subjects Having an Ileostomy
The purpose was to investigate the performance of a new ostomy device measured with a measuring device.
- Trial name
- NCT03439241
- Testing
- Coloplast ostomy device
- Where
- Denmark
- Volunteers
- 20 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
Obesity
Endoscopic Suturing System for Tissue Apposition
The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight…
- Trial name
- NCT00495222
- Testing
- Tissue plication, Endoscopic Suturing System
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Ethicon Endo-Surgery
Ostomy
Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology
An ostomy is defined by the connection of a viscera to the skin, outside its natural location, by diversion from the digestive or urinary tract. The bodily injury, i.e.
- Trial name
- QoLMio (NCT04635215)
- Testing
- Sensura Mio Bodyfit technology ostomy pouches
- Where
- 78 sites in France
- Volunteers
- 195 people
- Sponsor
- Laboratoires Coloplast S.A.S
Ileostomy - Stoma
Evaluation of the Influence of Output on a Newly Develop Adhesive
The study investigates the impact real output has on the adhesion of adhesives.
- Trial name
- NCT02886403
- Testing
- Standard adhesive strip, New adhesive strip
- Where
- Denmark
- Volunteers
- 5 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.
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
Colostomy
One Piece Closed Pouch in Subjects With a Colostomy
A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
- Trial name
- NCT01935999
- Testing
- One piece closed pouch
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- ConvaTec Inc.
Stoma Site Leakage
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
- Trial name
- NCT04544566
- Testing
- Test product A, Test product B, Comparator
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Coloplast A/S
Ostomy
Study on the Stoma Appliance Flexima®/Softima® 3S
To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up. The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's…
- Trial name
- KISSS (NCT03133585)
- Testing
- 2 piece appliance for stomy
- Where
- 2 sites in France
- Volunteers
- 1,500 people
- Sponsor
- BBraun Medical SAS
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
Healthy
Controlled Randomized Study With Athena Base Plate Versus SenSura Base Plate on Perspiring Skin
Aim The aim of the Athena project is to develop an ostomy product that is softer and more flexible in order to improve the comfort for people with a stoma.
- Trial name
- NCT01245413
- Testing
- SenSura, Athena
- Where
- Denmark
- Volunteers
- 32 people, healthy volunteers welcome
- 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