Clinical trials: Ostomy
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 - Stoma
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
The aim of the current clinical investigation is to evaluate a new filter
- Trial name
- NCT01272869
- Testing
- SenSura, Morfeus
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
Stoma, Ostomy
MOBILE EDUCATION AND COMFORT IN OSTOMY PATIENTS
Purpose of the Study This study aims to understand whether a mobile education program can improve comfort levels in people living with a stoma.
- Conditions
- Stoma, Ostomy, Mobile Application
- Trial name
- STOMA-PLUS (NCT07358286)
- Testing
- Mobile Education Program Based on Kolcaba's Comfort Theory
- Volunteers
- 68 people
- Sponsor
- Ege University
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
Ileostomy, Colostomy
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
- Trial name
- NCT02362360
- Testing
- Coloplast Test Product, Comparator (Hollister)
- Where
- 5 sites in Denmark, Germany and 2 more
- Volunteers
- 52 people
- Sponsor
- Coloplast A/S
Quality of Life, Mobile Apps
The Effectiveness of APP Intervention on Home Self-care Ability and Quality of Life of Patients With Intestinal Stoma
Colorectal cancer is the third leading cause of cancer-related deaths in Taiwan. In the United States, colorectal cancer is the third most common cancer diagnosis and mortality.
- Conditions
- Quality of Life, Mobile Apps, Ostomy
- Trial name
- NCT04943822
- Testing
- A new APP
- Where
- Taiwan
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Stoma Ileostomy, Surgical Wound
The Use of Post-operative NPWT Dressing in the Prevention of Infectious Complications After Ostomy Reversal Surgery
Introduction: Although negative-pressure wound therapy (NPWT) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear.
- Conditions
- Stoma Ileostomy, Surgical Wound, Negative Pressure Wound Therapy, Postoperative Wound Infection
- Trial name
- NCT04088162
- Testing
- Postoperative Negative Pressure Wound Therapy KCI NANOVA
- Where
- 2 sites in Poland
- Volunteers
- 70 people
- Sponsor
- Michał Pędziwiatr
Ostomy, Living in Roskilde County
Skin Problems in Ostomy Patients: An Epidemiological Study
Peristomal skin complications are thought to be common but the exact frequency and cause of these complications are unknown. We have sought to document the incidence of cutaneous peristomal problems and to find risk factors that…
- Conditions
- Ostomy, Living in Roskilde County, Persons More Than 18 Years of Age, Willingness to Participate
- Trial name
- NCT00391508
- Where
- Denmark
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Zealand University Hospital
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
Intestinal Obstruction, Gastroschisis
Ostomy in Continuity or Conventional Ileostomy: a Retrospective Multicentric Analysis
Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine.
- Conditions
- Intestinal Obstruction, Gastroschisis, Enterocolitis, Necrotizing, Hirschsprung Disease
- Trial name
- StomaPed (NCT04213976)
- Testing
- Ileostomy
- Where
- 5 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Angers
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.
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
Colostomy
Clinical Investigation for New Filter to Ostomy Bags
The aim of the current clinical investigation is to evaluate a new filter.
- Trial name
- NCT01273038
- Testing
- Morfeus, SenSura
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
Enterostomy
Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.
- Trial name
- NCT03572673
- Testing
- Flexima 3S, New 2-piece ostomy appliance
- Where
- 2 sites in Malaysia
- Volunteers
- 38 people
- Sponsor
- BBraun Medical SAS
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
Anesthesia, Ostomy
Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery
The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.
- Trial name
- NCT01136668
- Testing
- Transversus Abdominis Plane Block, Standard
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- The Hospital for Sick Children