Clinical trials: Ileostomy
Ileostomy - Stoma
Evaluation of the Influence of Output on Skin Wearing a New Adhesive
The purpose is to investigate the impact real output has on the peristomal skin covered by a newly developed adhesive.
- Trial name
- NCT03200431
- Testing
- New adhesive strip
- Where
- Denmark
- Volunteers
- 6 people
- Sponsor
- Coloplast A/S
Short Bowel Syndrome, Short Gut Syndrome
A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
MP-101 will be evaluated in this study to see if it is safe and tolerable.
- Conditions
- Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Gut
- Trial name
- NCT02246816
- Testing
- 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
- Where
- 5 sites in United States
- Sponsor
- Marathon Pharmaceuticals, LLC
Ileostomy
A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy
Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing.
- Trial name
- U366 (NCT01782196)
- Testing
- Enhanced one piece drainable pouch with Type A mouldable adhesive, Enhanced one piece drainable pouch with Type B mouldable adhesive
- Where
- 5 sites in United Kingdom
- Volunteers
- 13 people
- Sponsor
- ConvaTec Inc.
Ileostomy-stoma
A Pilot Evaluation of Adhesives and How They Are Impacted by Output
This study investigates the impact of real output on the adhesion of two adhesives.
- Trial name
- NCT02886442
- Testing
- Standard adhesive strip, New adhesive strip
- Where
- Denmark
- Volunteers
- 4 people
- Sponsor
- Coloplast A/S
Obesity, Type 2 Diabetes Mellitus (T2DM)
Magnetic Duodeno-Ileal Chile Study
The objective of the MagDI Chile Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side…
- Trial name
- NCT06613724
- Testing
- Magnet System, DI Biofragmentable
- Where
- Chile
- Volunteers
- 10 people
- Sponsor
- GT Metabolic Solutions, Inc.
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
Crohn's Disease
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
The purpose of this study is to evaluate safety, tolerability, and effect on mucosal repair of AZD7798 compared with placebo in participants with active ileal Crohn's disease and an ileostomy.
- Trial name
- CALLISTO (NCT06681324)
- Testing
- AZD7798
- Where
- 17 sites in Belgium, Italy and 5 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Intestinal Failure, Enterocutaneous Fistula
Chyme Reinfusion for Type 2 Intestinal Failure
This project aims to introduce and evaluate a novel assistive prosthetic system that helps prevent and treat nutrient and fluid loss from enterocutaneous fistulas.
- Conditions
- Intestinal Failure, Enterocutaneous Fistula, Ileostomy - Stoma, High Output Stoma
- Trial name
- REINFUSE (NCT04577456)
- Testing
- The Insides System
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 44 people
- Sponsor
- The Insides Company
Stoma Site Leakage, Quality of Life
The Nordic Consensus Study
A Body Assessment Tool was developed to provide nurses with a more structured approach when choosing ostomy products. The Body Assessment Tool will to be evaluated in clinical settings.
- Conditions
- Stoma Site Leakage, Quality of Life, Nurse's Role, Stoma Ileostomy
- Trial name
- NCS (NCT04763863)
- Testing
- Body Assessment Tool, Clinical usability evaluation of the Body Assessment Tool
- Where
- Denmark
- Volunteers
- 121 people
- Sponsor
- Coloplast A/S
Ostomy, Ileostomy - Stoma
CP384 - Ostomy Care (OC) PRO Panel Plan
The aim is to create an electronic patient reported outcome (e-PRO) based registry, specifically for subjects living with a stoma (ileostomy, colostomy or urostomy).
- Conditions
- Ostomy, Ileostomy - Stoma, Urostomy
- Trial name
- 384 PRO Panel (NCT07589907)
- Volunteers
- 1,000 people
- Sponsor
- Coloplast A/S
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.
Stoma Ileostomy
Safety and Performance of New 1-piece Ostomy Product
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
- Trial name
- NCT01800916
- Testing
- Coloplast Adhesive baseplate A, Coloplast Adhesive baseplate B, Coloplast Adhesive baseplate C
- Where
- Denmark
- Volunteers
- 65 people
- Sponsor
- Coloplast A/S
Stoma - Ileostomy
Feasibility of a Newly Developed Ostomy Prototype
Despite the development of better stoma products, individuals with intestinal stomas can experience leakage problems, which negatively affect their quality of life.
- Trial name
- NCT07146035
- Testing
- CP369 Feasibility of a newly developed ostomy prototype (only one intervention)
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Investigation of Three Newly Developed 2-piece Convex Base-plates in Subjects With Ileostomy
To investigate the performance and safety of the three 2-piece convex ostomy appliances
- Trial name
- NCT01957397
- Testing
- Coloplast Test 1, Coloplast Test 2, Coloplast Test 3
- Where
- Denmark
- Volunteers
- 26 people
- Sponsor
- Coloplast A/S
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
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 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
Ileostomy
An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products
The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.
- Trial name
- NCT02351817
- Testing
- Test A, Test B, Baseline
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Coloplast A/S
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
Evaluation of a New Supporting Ostomy Product
The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their…
- Trial name
- NCT04374890
- Testing
- CP308
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Coloplast A/S