Clinical trials: Ostomy
Leakage, Skin Condition
Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy
Introduction: It is not an illness to have an ostomy, even though it is an indication of previous serious illness, such as cancer, which is the reason for approximately 80% of all ostomy operations.
- Trial name
- NCT01448629
- Testing
- Standard Care, River
- Sponsor
- Coloplast A/S
Peristomal Skin Complication
A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology
This investigation is a randomized, controlled, open-label, comparative, cross-over, multicenter investigation, with two test periods.
- Trial name
- CP338 (NCT04868617)
- Testing
- ATTRACT-I
- Where
- Denmark
- Volunteers
- 89 people
- Sponsor
- Coloplast A/S
Stoma Colostomy
Performance Study of Newly Developed Ostomy Products
The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies.
- Trial name
- NCT01513330
- Testing
- SenSura Mio, Standard Care
- Where
- Germany
- Volunteers
- 122 people
- Sponsor
- Coloplast A/S
C. Diff. Infections
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.
- Trial name
- NCT04893239
- Testing
- LMN-201 Anti-toxin B VHH-1, LMN-201 Anti-toxin B VHH-2, LMN-201 Anti-toxin B VHH-3
- Where
- 3 sites in Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lumen Bioscience, Inc.
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
Ostomy
Observational Study of Ostomy Consumers
The purpose of this longitudinal prospective observational study is to collect electronic Patient Reported Outcome (ePRO) data over a 7-year period directly from people living with an ostomy and their caregivers (participants…
- Trial name
- OSO (NCT03715179)
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Hollister Incorporated
Ostomy
The Advocate Study
Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.
- Trial name
- NCT02401412
- Testing
- Test Ostomy Barrier, Control Ostomy Barrier
- Where
- 12 sites in United States, Canada
- Volunteers
- 170 people
- Sponsor
- Hollister Incorporated
Ostomy
Observational Evaluation of the Peristomal Skin Condition in Ostomates
The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.
- Trial name
- OSMOSE (NCT01526967)
- Where
- 13 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- ConvaTec Inc.
Stoma
Coloplast DialogueStudy
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
- Trial name
- NCT00626821
- Testing
- SenSura
- Where
- United States
- Volunteers
- 3,017 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigation of the Performance of Ostomy Base Plate
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2.
- Trial name
- NCT01103466
- Testing
- Atlas, SenSura, Conform 2
- Where
- Denmark
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece
The aim of the current investigation is to investigate the performance of a new 2-piece ostomy product
- Trial name
- NCT01957553
- Testing
- Coloplast test product, SenSura
- Where
- 17 sites in Belgium, Denmark and 3 more
- Volunteers
- 130 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
Stoma Ileostomy
Safety and Performance of New 1-piece Ostomy Product
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
- Trial name
- NCT01800916
- Testing
- Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B, Coloplast Adhesive baseplate C
- Where
- Denmark
- Volunteers
- 65 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Clinical Investigation Exploring Two Ostomy Product Prototypes
Two ostomy product prototypes (Test product A and B) will be tested in this investigation. All subjects will test both Test product A and B, with a minimum of 7 days apart.
- Trial name
- NCT06237686
- Testing
- CP363
- Where
- Denmark
- Volunteers
- 11 people
- Sponsor
- Coloplast A/S
Ostomy
Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula
The objective of this pilot study is to evaluate the feasibility, safety and efficacy of 3M™ Cavilon™ Advanced Skin Protectant when used in the management of damaged skin exposed to caustic body fluids from an ostomy, drain site…
- Trial name
- NCT03057132
- Testing
- Cavilon Advanced Skin Protectant
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Solventum US LLC
Rectal Cancer Surgery
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current…
- Trial name
- NCT07429110
- Testing
- ColoSeal ICD System, Protective Diverting Ostomy
- Where
- 9 sites in United States, New Zealand
- Volunteers
- 250 people
- Sponsor
- Averto Medical, Inc.
Ileostomy - Stoma
Assessment of New Ostomy Devices in Subjects Having an Ileostomy
The study investigates the performance of three new adhesives with regard to leakage and the skin condition.
- Trial name
- NCT03427203
- Testing
- SenSura Mio, Coloplast Ostomy device 1, Coloplast Ostomy device
- Where
- 3 sites in Denmark, Netherlands
- Volunteers
- 35 people
- Sponsor
- Coloplast A/S
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
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
Colorectal Cancer
ColoSeal™ ICD System Safety and Feasibility Studies
The studies aim to evaluate the safety and feasibility of the ColoSeal Intraluminal Colonic Diversion (ICD) System in two prospective, multicenter, single-arm studies.
- Trial name
- PROTECT I (NCT06402188)
- Testing
- ColoSeal ICD Device
- Where
- 3 sites in Armenia, Georgia and 1 more
- Volunteers
- 90 people
- Sponsor
- Averto Medical, Inc.