Clinical trials: Extravasation
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
Urinary Incontinence, Stress
Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)
The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder).
- Trial name
- NCT00190827
- Testing
- duloxetine
- Where
- 8 sites in Brazil, Canada and 6 more
- Volunteers
- 500 people
- Sponsor
- Eli Lilly and Company
Ostomy
Evaluation of an Ostomy Leakage Detection System
This study will evaluate the safety and efficacy of an ostomy leakage detection system.
- Trial name
- NCT06547905
- Testing
- Ostomy Leakage Detection System
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- Hollister Incorporated
Infiltration, IV Infiltration
Ultrasound Detection of Peripheral IV Infiltration
The purpose of this study is to determine whether commercial ultrasound imaging systems can discern normal from infiltrated tissue near a peripheral intravenous site.
- Trial name
- NCT01800552
- Testing
- Intentional infiltration of a peripheral IV site
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Dura Mater Nick Cut or Tear, Hemostatis
Hemopatch Performance Evaluation: A Prospective Observational Registry
To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.
- Conditions
- Dura Mater Nick Cut or Tear, Hemostatis, Air Leakage, Body Fluid Leakage
- Trial name
- NCT03392662
- Testing
- Hemopatch
- Where
- 15 sites in Austria, Czechia and 3 more
- Volunteers
- 621 people
- Sponsor
- Baxter Healthcare Corporation
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.
Urinary Incontinence Due to Cognitive Impairment, Urinary Incontinence
Use of Continence Care Protocol in UK Nursing Homes.
This is a retrospective cohort study. In the investigation the clinical use of the Skin and leakage protocol (SLEP) is to be investigated.
- Trial name
- NCT06100458
- Testing
- Skin and leakage protocol
- Where
- United Kingdom
- Volunteers
- 49 people
- Sponsor
- Essity Hygiene and Health AB
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
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
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.
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
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
Diabetes, Diabetes Mellitus, Type 1
Comparison of 2 NovoFine® Needles on the Reflux of Insulin
This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin…
- Conditions
- Diabetes, Diabetes Mellitus, Type 1, Delivery Systems
- Trial name
- NCT00872560
- Testing
- NovoFine® needle 6 mm, NovoFine® needle 8 mm
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
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
C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis…
- Conditions
- C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract, Gastric Anastomosis (Site), Gastrointestinal Neoplasms
- Trial name
- PROMEGAT (NCT02080702)
- Testing
- Monosyn
- Where
- 5 sites in Malaysia, Philippines and 2 more
- Volunteers
- 106 people
- Sponsor
- Aesculap AG
Cerebrospinal Fluid Leakage
Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair
Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft, either BIOSCAFF®H or DuraGen®, into the skull…
- Trial name
- NCT06419855
- Testing
- Human collagen matrix graft, Bovine collagen matrix graft
- Where
- 4 sites in Mexico
- Volunteers
- 2 people
- Sponsor
- Top Health S.A.P.I DE C.V.
Anastomotic Leakage
SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit
This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an…
- Trial name
- NCT02881359
- Testing
- LifeSeal® Kit
- Where
- 8 sites in Belgium, Netherlands
- Volunteers
- 200 people
- Sponsor
- LifeBond Ltd.
Colorectal Surgery, Colorectal Cancer
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an…
- Conditions
- Colorectal Surgery, Colorectal Cancer, Rectal/Anal, Ileostomy - Stoma
- Trial name
- COLO-BT (NCT05826743)
- Testing
- COLO BT™, Stoma Creation
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- JSR Medical Co., Ltd.
Pulmonary Diseases, Intraoperative Complications
TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)
The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage…
- Trial name
- NCT00293514
- Testing
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Where
- Denmark
- Sponsor
- Nycomed
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