Clinical trials: Colostomy
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
Stoma Ileostomy, Stoma Colostomy
Quality of Life Impact After Enhanced Follow-up of Ostomy Patients
In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.
- Conditions
- Stoma Ileostomy, Stoma Colostomy, Quality of Life
- Trial name
- StomaCare (NCT05076669)
- Testing
- stoma follow-up, standard of care
- Where
- 10 sites in France
- Volunteers
- 350 people
- Sponsor
- FSK
Diverticulum, Colon, Colorectal Neoplasms
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- RETROPRESS (NCT01301417)
- Testing
- ColonRing™
- Where
- United States
- Volunteers
- 171 people
- Sponsor
- novoGI
Colostomy Stoma
Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
- Trial name
- NCT03108105
- Testing
- AOS-C2001-B
- Where
- France
- Volunteers
- 30 people
- Sponsor
- BBraun Medical SAS
Colostomy
Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy
The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.
- Trial name
- NCT02223104
- Testing
- Flexima Active, Sensura
- Where
- France
- Volunteers
- 70 people
- Sponsor
- BBraun Medical SAS
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
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
Ileostomy - Stoma, Colostomy - Stoma
Investigation of Two Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy and Colostomy
The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.
- Trial name
- NCT01957462
- Testing
- Coloplast Test V, Coloplast Test X
- Where
- Denmark
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
Diverticulum, Colon, Colorectal Neoplasms
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- NCT01880918
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- novoGI
Colostomy
Multi-National Phase III Vitala™ 12-Hour Wear Test
The purpose of this clinical study is to demonstrate that the Vitala™ Continence Control Device is both safe and effective when worn up to 12 hours per day.
- Trial name
- NCT00902252
- Testing
- Usual, Natura®, Vitala™
- Where
- 12 sites in United States, Germany and 1 more
- Volunteers
- 78 people
- Sponsor
- ConvaTec 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
Colostomy - Stoma, Colostomy Complications
Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication
This 3-way crossover study aims to evaluate whether colostomy bags with an active chamber filter system reduce the incidence of filter-related complications, such as ballooning and pancaking, help neutralise odour, and minimise…
- Trial name
- BREEZE-01 (NCT06739174)
- Testing
- Confidence Be 1-Piece Closed Bag, Confidence Natural 1-Piece Closed Bag, Confidence Be go 1-Piece Closed Bag
- Where
- United Kingdom
- Volunteers
- 27 people
- Sponsor
- Salts Healthcare
Ileostomy, Colostomy
SCOPE - Single-Point Classification Observational Peristomal Evaluation
Study to create an ostomy dataset and collect stoma photos to enable evaluation of images digitally versus an in-person ostomy skin assessment.
- Conditions
- Ileostomy, Colostomy, Urostomy
- Trial name
- NCT06614491
- Where
- 4 sites in Brazil, Colombia
- Volunteers
- 605 people
- Sponsor
- ConvaTec Inc.
Colostomy, Ileostomy
User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
The primary aim of this study is to demonstrate the maintenance of healthy peri-stomal skin over a two month period in subjects who use ConvaTec Moldable Technology™ Skin Barriers as part of their standard protocol of care…
- Conditions
- Colostomy, Ileostomy, Urostomy
- Trial name
- OSMOSE (NCT02499588)
- Testing
- Esteem Plus with ConvaTec Moldable Technology, Natura with ConvaTec Moldable Technology, Natura Accordion with ConvaTec Moldable Technology
- Where
- Poland
- Volunteers
- 600 people
- Sponsor
- ConvaTec Inc.
Ileostomy - Stoma, Colostomy Stoma
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
The study investigates the performance of a new adhesive with regard to the skin condition
- Trial name
- NCT03770078
- Testing
- Test Product A
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 23 people
- Sponsor
- Coloplast A/S
Colostomy Stoma
NM-IL-12 (rHuIL-12) in Subjects With Open Surgical Wounds
The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative to standard of care (SOC; control) in subjects with open surgical wounds.
- Trial name
- NCT02544061
- Testing
- NM-IL-12
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Neumedicines Inc.
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
Rectal Cancer, Rectal Tumor
Efficacy and Safety of the CG-100 Intraluminal Bypass Device
A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.
- Conditions
- Rectal Cancer, Rectal Tumor, Rectal/Anal
- Trial name
- NCT04184973
- Testing
- CG-100 intraluminal bypass device, Stoma
- Where
- 10 sites in United States, Germany and 3 more
- Volunteers
- 250 people
- Sponsor
- Colospan Ltd.