Clinical trials: Ileostomy - Stoma
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
Rectal Cancer, Ileostomy; Functional Disturbance
Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer (GRECCAR17)
GRECCAR 17 will be the first prospective and randomized trial to assess a tailored policy in the use of defunctioning stoma after TME according to the personalized risk of anastomotic leakage.
- Trial name
- GRECCAR17 (NCT05233787)
- Testing
- Tailored use of defunctioning stoma after TME, Systematic use of defunctioning stoma
- Where
- 28 sites in France
- Volunteers
- 212 people
- Sponsor
- University Hospital, Bordeaux
Colorectal Cancer, Stoma Ileostomy
SafeHeal Diverting Ileostomy Pivotal Study
This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications.
- Trial name
- SH-SOC23 (NCT06152276)
- Testing
- Diverting loop ileostomy
- Where
- 22 sites in United States, Belgium and 2 more
- Volunteers
- 132 people
- Sponsor
- SafeHeal Inc
Stoma Ileostomy
CP376 OCT Exploratory Skin Study
An explorative study investigating differences on the peristomal skin and the abdominal skin by Optimal Coherence (OCT) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled.
- Trial name
- NCT06965140
- Testing
- flat 1-piece open ostomy device
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Coloplast A/S
Peristomal Skin Complication
Preliminary Evaluation of CASTLE Barrier Prototype UK
The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.
- Trial name
- NCT01530087
- Testing
- CASTLE barrier
- Where
- United Kingdom
- Volunteers
- 3 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
Diverting Ileostomy, Middle and Low Rectal Cancer
Diverting Ileostomy and Anal Functional Outcomes After Anus Preservation Surgery
Analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.
- Conditions
- Diverting Ileostomy, Middle and Low Rectal Cancer, Functional Outcome, Stoma Complications
- Trial name
- NCT04776421
- Testing
- Diverting ileostomy
- Volunteers
- 300 people
- Sponsor
- The First Hospital of Jilin University
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
Ulcerative Colitis, Ileal Pouch
Short Versus Long Interval to Ileostomy Reversal After Ileal Pouch Surgery
In patients with ulcerative or indeterminate colitis who undergo ileal pouch anal anastomosis and diverting loop ileostomy (IPAA) surgery* a short interval to loop ileostomy reversal will result in differences in complications…
- Conditions
- Ulcerative Colitis, Ileal Pouch, Ileostomy - Stoma
- Trial name
- SLIRPS (NCT03587519)
- Testing
- Early, Late
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- University of Colorado, Denver
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, Rectal Cancer
Alterations of Gut Microbiome, Function, and Its Intervention After Defunctioning Ileostomy
This study focused on the alterations of gut microbiome and function during defunctioning ileostomy, and observed the effects of probiotic intervention on intestinal microbiome and function.
- Conditions
- Ileostomy - Stoma, Rectal Cancer, Microbial Disease, Intestinal Functional Disorder
- Trial name
- NCT05759741
- Testing
- MIYAIRI 588
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Huashan Hospital
Colostomy Stoma, Ileostomy - Stoma
Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene
To evaluate the efficacy of the application of a neutral gel based on ecological extra virgin olive oil for peristomal skin hygiene in individuals with colostomy and ileostomy.
- Conditions
- Colostomy Stoma, Ileostomy - Stoma, Peristomal Skin Complication
- Trial name
- gAOVEstoma (NCT05289765)
- Testing
- A natural neutral Ecological Extra Virgin Olive Oil based gel, A conventional neutral gel, without Ecological Extra Virgin Olive Oil or any other olive oil-derived products
- Where
- 2 sites in Spain
- Volunteers
- 27 people
- Sponsor
- Universidad de Granada
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
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
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
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.
- Trial name
- NCT03619226
- Testing
- test patch
- Where
- Denmark
- Volunteers
- 6 people, healthy volunteers welcome
- 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
Enterostomy, Stoma Ileostomy
Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
The study is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice and according to Instructions…
- Conditions
- Enterostomy, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT05373888
- Testing
- Flexima®/Softima® stoma bags
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- BBraun Medical SAS
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