Clinical trials: Leakage
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
Injection Site, Injection Site Reaction
Sorrel 25R Injector - Sorrel Clinical Study Protocol
A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.
- Conditions
- Injection Site, Injection Site Reaction, Injection Site Irritation
- Trial name
- NCT05221333
- Testing
- Sorrel Wearable Injector
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eitan Medical
Infiltration of Peripheral IV Therapy
ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
- Trial name
- NCT02120443
- Testing
- ivWatch Model 400
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Urinary Catheters, Bladder Pain and Discomfort
FLUME Catheter Comfort Study
The Flume catheter is a commercially available (FDA 510(k) cleared) urethral catheter with an innovative catheter design. The traditional Foley catheter design includes a protruding tip with drainage holes.
- Conditions
- Urinary Catheters, Bladder Pain and Discomfort, Urine Leakage, Bladder Spasm
- Trial name
- NCT05785858
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- The Flume Catheter Company Ltd
Leakage, Skin Condition
Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care Ostomy Products in Subjects Ileostomy
Introduction: It is not an illness to have an ostomy, even though it is an indication of previous serious illness, such as cancer, which is the reason for approximately 80% of all ostomy operations.
- Trial name
- NCT01448629
- Testing
- Standard Care, River
- Sponsor
- Coloplast A/S
Stress Urinary Incontinence
A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)
Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients…
- Trial name
- NCT00196521
- Testing
- Tension-free vaginal tape obturator system
- Where
- 19 sites in United States, Canada and 5 more
- Volunteers
- 300 people
- Sponsor
- Ethicon, Inc.
Dengue Shock Syndrome
Effect of Hypertonic Sodium Lactate on sVCAM-1 Level as Surrogate Marker of Endothelial Capillary Leakage in Pediatric Dengue Shock Syndrome Patients (DSS)
Dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) are among the leading causes of pediatric hospitalization in Asia.Mortality rates range from 1% at centres experienced in fluid resuscitation, to upto 44% in…
- Trial name
- NCT00966628
- Testing
- Hypertonic sodium lactate, Ringer's lactate
- Where
- Indonesia
- Volunteers
- 50 people
- Sponsor
- Innogene Kalbiotech Pte. Ltd
Gastrointestinal Anastomotic Complication
a Study to Investigate the Efficacy, and Safety of the Colovac Colorectal Anastomosis Protection Device.
The purpose of this study is to evaluate theColovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or…
- Trial name
- SAFE-1 (NCT03352570)
- Testing
- COLOVAC
- Where
- 3 sites in Belgium, France
- Volunteers
- 15 people
- Sponsor
- Safeheal
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
HIV Infections
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables.
- Trial name
- NCT06970223
- Testing
- Cabotegravir long-acting, Lenacapavir long-acting
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Intravenous Infiltration, Extravasation of Diagnostic and Therapeutic Materials
Optical Detection of Intravenous Infiltration
The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed for monitoring the intravenous infusion site for infiltration.
- Trial name
- NCT01126710
- Where
- United States
- Volunteers
- 263 people
- Sponsor
- CW Optics, Inc.
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
Urinary Incontinence, Stress, Mixed Incontinence
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse.
- Conditions
- Urinary Incontinence, Stress, Mixed Incontinence, Vaginal Vault Prolapse
- Trial name
- NCT00223106
- Testing
- Vaginal Sling
- Where
- United States
- Volunteers
- 467 people
- Sponsor
- Medtronic - MITG
Menstruation
Prospective, Explorative, Research Study with Women to Investigate Menstruation Leakage At Night
The aim of this study is to investigate why and when menstruation leakages occur during sleep while using protective pads at night.
- Trial name
- NCT06637787
- Testing
- Pads
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Essity Hygiene and Health AB
Infiltration, Extravasation
Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation
The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events.
- Conditions
- Infiltration, Extravasation, IV Infiltration, IV Extravasation
- Trial name
- NCT01476293
- Where
- United States
- Volunteers
- 139 people
- Sponsor
- ivWatch, LLC
Type 2 Diabetes Mellitus
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period.
- Trial name
- NCT00365781
- Testing
- ISIS 113715
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Anastomotic Leak
Economic Evaluation of Stream™ Platform
This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platform for early detection of…
- Trial name
- CostAL (NCT05994625)
- Testing
- Stream™ Platform, Stream™ Platform with Risk Score Omitted
- Where
- 2 sites in Canada
- Volunteers
- 215 people
- Sponsor
- FluidAI Medical
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
Extravasations of Anthracycline Anti-cancer Agents
A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in the treatment of accidental extravasation of anthracycline anti-cancer agents.
- Trial name
- NCT01596088
- Testing
- Dexrazoxane
- Where
- Japan
- Volunteers
- 2 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
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