Clinical trials: Ostomy
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
Self-management, Self Efficacy
Effects of Transtheoretical Model-based Intervention on the Self-management of Patients With an Ostomy
Colorectal cancer (CRC) is one of the most commonly diagnosed cancers worldwide. The main treatment approach is radical surgery, and the auxiliary treatment may be chemotherapy, radiotherapy, immunotherapy and other supportive…
- Trial name
- NCT03681821
- Testing
- Transtheoretical Model (TTM)-based Intervention
- Volunteers
- 94 people
- Sponsor
- Central South University
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
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
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
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 - 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 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
Colorectal Cancer, Quality of Life
Peristomal Skin Complications and Quality of Life
This study is a single blind semi-experimental study. Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery.
- Conditions
- Colorectal Cancer, Quality of Life, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT04375930
- Testing
- STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION, Control
- Where
- Turkey (Türkiye)
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dokuz Eylul University
Colorectal Cancer, Bladder Cancer
Connecting Audio and Radio Sensing Systems to Improve Care at Home
This study aims to assess the usability of the innovative Audio + Radio (AURA) system in enhancing personalized supportive care for cancer patients and caregivers during the post-ostomy care transition by collecting information…
- Conditions
- Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer
- Trial name
- AURA (NCT05344950)
- Testing
- Audio + Radio (AURA)
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
3D Printing, Ostomy
3D Printed Personalized Ostomy Appliance
The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is: Whether or not a 3D scan of a stoma reduces leakages and improves…
- Conditions
- 3D Printing, Ostomy, Leakage
- Trial name
- 3DPPOA (NCT06310070)
- Testing
- 3D Printed Personalized Ostomy Appliance
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Carilion Clinic
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
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
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
Diverticular Disease of Colon, Colostomy Complication
Comparing Hartmann's Procedure and Primary Resection With Anastomosis in Hinchey III-IV Diverticulitis: Focus on Ostomy Closure and Long-Term Outcomes
Brief Summary This multicenter study compares the effectiveness of primary anastomosis with diverting loop ileostomy to Hartmann's procedure for managing perforated sigmoid diverticulitis in stable patients.
- Conditions
- Diverticular Disease of Colon, Colostomy Complication, Colostomy - Stoma
- Trial name
- ARES (NCT06794905)
- Volunteers
- 578 people
- Sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
Diverticular Disease of Colon, Colostomy - Stoma
ARES Trial: Approach to Resection and Evaluation in Severe Diverticulitis
This observational study was conducted across five surgical centers in Italy, including both academic and community hospitals, from January 2017 to December 2022.
- Conditions
- Diverticular Disease of Colon, Colostomy - Stoma, Loop Ileostomies
- Trial name
- ARES (NCT07094594)
- Where
- Italy
- Volunteers
- 578 people
- Sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
Stoma Colostomy, Stoma Ileostomy
Management Of Stoma In Patients Younger Than 3 Months Old
Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also…
- Conditions
- Stoma Colostomy, Stoma Ileostomy, Neonatal Disease
- Trial name
- STOMP (NCT06458699)
- Where
- France
- Volunteers
- 82 people
- Sponsor
- University Hospital, Clermont-Ferrand
Colostomy
Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
- Trial name
- NCT01243294
- Testing
- SS, SenSura
- Where
- Denmark
- Volunteers
- 56 people
- 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
Ostomy - Ileostomy or Colostomy
The Influence of Adhesive Wafer Design on Fit to the Body
The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
- Trial name
- NCT02176954
- Testing
- Test A, Test B, Comparator
- Where
- 10 sites in Netherlands, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Coloplast A/S