Clinical trials: Leakage
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
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
Leakage, Skin Condition
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.
- Trial name
- NCT01517178
- Testing
- New ostomy base plate (SS), Standard Care base plate
- Where
- 11 sites in Denmark, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Coloplast A/S
Rupture of Amniotic Membranes
Analysis of ROM Plus to Detect Rupture of Membranes
Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in clinical practice, and iii) that the ROM…
- Trial name
- NCT01366443
- Testing
- Sterile speculum exam, ROM Plus Exam, Chart Reveiw
- Where
- United States
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- Clinical Innovations, LLC
Urinary Bladder, Overactive
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency.
- Trial name
- NCT01302054
- Testing
- Fesoterodine 8 mg
- Where
- 176 sites in United States, Bulgaria and 13 more
- Volunteers
- 990 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles
Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may…
- Trial name
- NCT00928057
- Testing
- 4mm x 32G pen needle, 8mm x 31G pen needle, 5mm x 31G pen needle
- Where
- 4 sites in United States
- Volunteers
- 173 people
- Sponsor
- Becton, Dickinson and Company
Infiltration of Peripheral IV Therapy
Optical Detection of Intravenous Infiltration:A Pilot Study
This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by…
- Trial name
- NCT02553421
- Testing
- ivWatch Model 400
- Where
- United States
- Volunteers
- 243 people
- Sponsor
- ivWatch, LLC
Minimally Invasive Surgical Procedures, Laparoscopy
Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery
This is a Post-Market Clinical Follow-up (PMCF) investigation to determine the long-term effectiveness and safety of the Multi-Fire Clip System in laparoscopic surgery.
- Conditions
- Minimally Invasive Surgical Procedures, Laparoscopy, Leakage of Cardiac Device
- Trial name
- RELAP (NCT05363813)
- Testing
- M/L-10 Multi-Fire Clip Applier and M/L-10 Clip Cartridge (Multi-Fire Clip System)
- Where
- 7 sites in Portugal, Spain
- Volunteers
- 245 people
- Sponsor
- Microline Surgical, Inc.
Respiratory Aspiration
The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery
Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from…
- Trial name
- NCT01539135
- Testing
- Methylene Blue
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medtronic - MITG
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
Bowel Incontinence
A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage
The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.
- Trial name
- REST (NCT01475474)
- Testing
- Renew Insert
- Where
- 3 sites in United States
- Volunteers
- 97 people
- Sponsor
- Renew Medical
Stoma Site Leakage
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.
- Trial name
- NCT04544566
- Testing
- Test product A, Test product B, Comparator
- Where
- Denmark
- Volunteers
- 12 people
- Sponsor
- Coloplast A/S
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
Injection Site Reaction
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints.
- Trial name
- NCT06093815
- Testing
- Injection
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
Fecal Incontinence, Bowel Dysfunction
LIBERATE - PRO: Eclipse™ System Registry
A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing…
- Conditions
- Fecal Incontinence, Bowel Dysfunction, Bowel Incontinence, Accidental Bowel Leakage
- Trial name
- LIBERATEPRO (NCT03028636)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Pelvalon, 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
Infiltration of Peripheral IV Therapy
ivWatch Model 400: Device Validation for Infiltrated Tissues
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT02123745
- Testing
- The ivWatch Model 400
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Colostomy Stoma, Ileostomy Stoma
The Influence of Baseplate Adhesive on the Degree of Leakage
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
- Trial name
- NCT01995357
- Testing
- Coloplast Test A, Coloplast Test B, Standard product
- Where
- Denmark
- Volunteers
- 22 people
- Sponsor
- Coloplast A/S
Cerebrospinal Fluid Leakage, Subdural
Study to Evaluate Safety & Effectiveness of Spinal Sealant
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
- Trial name
- NCT00444067
- Testing
- Spinal Sealant, Standard of Care
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Integra LifeSciences Corporation
Fecal Incontinence
Effects of an Anal Insert Device in Fecal Incontinence
The purpose of this research is to test the effects of an inserted anal device on fecal incontinence (accidental bowel leakage) in patients who have persistent symptoms despite other conservative therapy.
- Trial name
- NCT03898778
- Testing
- Minnesota Medical Technologies Anal Insert Device
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Minnesota Medical Technologies