Clinical trials: Ileostomy
Colon Cancer, Rectal Cancer
Stoma Closure and Reinforcement Trial
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…
- Conditions
- Colon Cancer, Rectal Cancer, Ileostomy - Stoma
- Trial name
- SCAR (NCT03750461)
- Testing
- Mesh Implantation
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Ileostomy
Zinc and Copper Absorption in Neonates With Bilious Losses
We propose to examine the absorption and excretion of zinc and copper in infants with ostomies. This will be accomplished by measuring baseline excretion and serum levels of zinc, copper, and ceruloplasmin, and by utilizing…
- Trial name
- NCT00738283
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Baylor College of Medicine
Ileostomy
An Exploratory Study Investigating Human Skin Reaction to Output
The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.
- Trial name
- NCT02351791
- Testing
- Patch 1, Patch 2, Patch 3
- Where
- Denmark
- Volunteers
- 22 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Transversus Abdominis Plane Blocks for Ileostomy Takedown: A Prospective Study
Consenting subjects will be randomized to receive injection of bupivacaine or placebo before surgery for ileostomy takedown (injection administered after general anesthesia has been administered).
- Trial name
- NCT01411917
- Testing
- Transversus abdominis plane block
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- University of Wisconsin, Madison
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
Healthy Volunteers With Ileostomy
A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy
A Phase 1b/2a, Multi-Center, Open-Label, 2-Period, Fixed-Sequence Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Healthy Adult Subjects with a Functioning Ileostomy
- Trial name
- NCT02473640
- Testing
- SYN-004, Esomeprazole, Ceftriaxone
- Where
- 2 sites in Canada
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Theriva Biologics, Inc.
Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy
Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of INTERCEED™
This is a prospective, randomized controlled study. The study population will include 220 subjects scheduled to undergo laparoscopic radical resection of rectal carcinoma with preventive ileostomy (Phase 1 operation).
- Trial name
- NCT03462563
- Testing
- INTERCEED™
- Where
- 12 sites in China
- Volunteers
- 175 people
- Sponsor
- Ethicon, Inc.
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
Ileostomy - Stoma
Efficacy of Ostom-i Alert System at Decreasing Dehydration Related Complications
The purpose of this study is to evaluate the efficacy of the Ostom-i device in decreasing readmission rates of subjects with new ileostomies in the first 30 days post-operatively.
- Trial name
- NCT02694757
- Testing
- Ostom-i device
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Massachusetts General Hospital
Leakage
A Clinical Investigation of New Ostomy Appliances
This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks.
- Trial name
- NCT01523756
- Testing
- test product 1: new ostomy base plate with Coloplast as manufacturer, test product 2: new ostomy base plate with Coloplast as manufacturer
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma, Colostomy Stoma
Investigation of Heylo, a Novel App Driven Digital Supporting Ostomy Product
People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
- Trial name
- NCT05200416
- Testing
- Heylo, Standard of Care
- Where
- Germany
- Volunteers
- 144 people
- Sponsor
- Coloplast A/S
Ileostomy - Stoma
Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
- Trial name
- NCT03416023
- Testing
- TIES® (Transcutaneous Implant Evacuation System)
- Where
- 4 sites in Sweden, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Ostomycure AB
Ileostomy - Stoma
Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
- Trial name
- NCT01799239
- Testing
- Test product, SenSura
- Where
- Sweden
- Volunteers
- 32 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
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
Colorectal Cancer, Bladder Cancer
Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)
This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance personalized supportive care for cancer…
- Conditions
- Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer
- Trial name
- PRISMS (NCT04492007)
- Testing
- Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
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
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 - 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
Ileostomy - Stoma
Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy
The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.
- Trial name
- NCT01994863
- Testing
- Coloplast Test product, Standard Care
- Where
- Netherlands
- Volunteers
- 23 people
- Sponsor
- Coloplast A/S