Clinical trials: Ileostomy
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
Healthy Volunteers
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.
- Trial name
- NCT02419001
- Testing
- Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC, Period 2 - Treatment Sequence AB
- Where
- 3 sites in United States, Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Theriva Biologics, Inc.
Stoma - Ileostomy
Investigation of Two Newly Developed 2-piece Convex Baseplates in Subjects With Ileostomy
The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances
- Trial name
- NCT01957475
- Testing
- Coloplast Test product Y, Coloplast Test product Z
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Coloplast A/S
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
Rectal Cancer, Ulcerative Colitis
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement…
- Conditions
- Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis
- Trial name
- NCT00663819
- Testing
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement, Staple line without reinforcement
- Where
- 16 sites in United States
- Volunteers
- 258 people
- Sponsor
- W.L.Gore & Associates
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
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
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
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.
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
Ileostomy
An Investigation of Ostomy Devices
Coloplast A/S has developed a new ostomy device in 8 versions. The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.
- Trial name
- NCT01514136
- Testing
- Ostomy appliance: convex 1-piece drainable
- Where
- Denmark
- Volunteers
- 32 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