Clinical trials: Ileostomy
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
Dehydration, Diverting Ileostomy, Loperamide
Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and familial adenomatous polyposis (FAP)…
- Trial name
- NCT02263365
- Testing
- Loperamide
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Cedars-Sinai Medical Center
Ileostomy; Complications, Ileostomy - Stoma
The Cascade Feasibility Pilot (Ileostomy)
Existing interventions including improving communication and self-care to improve readmission of patients undergoing high risk colorectal surgery involving new ileostomy formation has shown limited results.
- Trial name
- NCT05048329
- Testing
- Non-invasive continuous remote monitoring with structured escalation pathway, Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Endeavor Health
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
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
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
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
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
Ostomy
Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
The purpose of this study is to evaluate patient satisfaction and quality of life in patients with ileostomy managed with or without the novel Ostom-i Alert device.
- Trial name
- NCT02472639
- Testing
- Ostom-i Alert Sensor, No Ostom-i Alert Sensor
- Volunteers
- 7 people
- Sponsor
- Cedars-Sinai Medical Center
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
Ileostomy - Stoma
Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy
To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances
- Trial name
- NCT01994876
- Testing
- Coloplast Test 1, Coloplast Test 2
- Where
- Netherlands
- Volunteers
- 18 people
- Sponsor
- Coloplast A/S
Stoma Ileostomy
Evaluation of the Peel Force of New Adhesives From the Skin
This study investigates the impact and adhesion of new adhesives to the skin.
- Trial name
- NCT03200444
- Testing
- Standard adhesive 1, Standard adhesive 2, Standard adhesive 3
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigation of the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
- Trial name
- NCT01957384
- Testing
- Coloplast Test product 1, Coloplast Test product 2, Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma, Colostomy
A Clinical Investigation Evaluating and Understanding Parameters Affecting the Performance of Ostomy Products
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
- Trial name
- NCT02517541
- Testing
- SenSura Mio Convex Soft
- Where
- 9 sites in United States, Netherlands and 2 more
- Volunteers
- 74 people
- Sponsor
- Coloplast A/S
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
Ileostomy - Stoma, Inflammatory Bowel Diseases
Stoma Closure and Reinforcement Trial ll
Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of…
- Trial name
- SCAR-ll (NCT04916067)
- Testing
- Mesh Implantation
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
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
Colorectal Cancer, Rectal Cancer
SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.
- Conditions
- Colorectal Cancer, Rectal Cancer, Rectal Tumor, Rectal/Anal
- Trial name
- SAFE-2 (NCT05010850)
- Testing
- Colovac, Stoma Creation
- Where
- 16 sites in United States, Belgium and 1 more
- Volunteers
- 18 people
- Sponsor
- SafeHeal Inc
Retraction of Colostomy
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B504
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 (NCT01509807)
- Testing
- IV morphine sulfate or Sponsor-approved equivalent, EXPAREL
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Pacira Pharmaceuticals, 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