Clinical trials: Medical Device Complication
Pulmonary Embolism, Medical Device Complication
Angel® Catheter Post Market Registry
This is a post-market, observational, retrospective multi-center Registry designed to gather information on the performance of the Angel® Catheter in general clinical practice.
- Conditions
- Pulmonary Embolism, Medical Device Complication, Deep Vein Thrombosis, Catheter Thrombosis
- Trial name
- NCT02917135
- Testing
- Angel® Catheter
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 2,000 people
- Sponsor
- BiO2 Medical
Treatment Outcome, Vascular Access
Reduction of Complications Associated With PICC Management
The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care…
- Conditions
- Treatment Outcome, Vascular Access, Vascular Access Device, Vascular Access Complication
- Trial name
- PICC managemen (NCT06944327)
- Testing
- MANAGEMENT CARE, traditional care
- Volunteers
- 460 people
- Sponsor
- Fundacion Miguel Servet
Thyroid Cancer
Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System
The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure Precise™, Covidien) in surgery for thyroid cancer.
- Trial name
- UCBEST (NCT01565486)
- Testing
- Ultrasonic coagulation device (Harmonic ACE® scalpel), bipolar energy sealing system (LigaSure Precise)
- Where
- South Korea
- Volunteers
- 304 people
- Sponsor
- Seoul St. Mary's Hospital
Newborn Complication, Newborn Morbidity
Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya.
- Trial name
- NCT05728307
- Testing
- neoGuard vital signs monitor
- Where
- Kenya
- Volunteers
- 3,000 people
- Sponsor
- Assumpta Solome Nantume
Cardiovascular Complication
Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device
In patients undergoing surgery under general anesthesia, the clinical utility of non-invasive hemodynamic status monitoring equipment using HemoVista is compared with invasive hemodynamic status monitoring equipment FloTrac.
- Trial name
- NCT05996965
- Testing
- HemoVista
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Seoul National University Hospital
IUCD Complication
Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion
To investigate whether vaginal isonicotinic acid hydrazide administered before the levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.
- Trial name
- NCT04500015
- Testing
- INH
- Where
- Egypt
- Volunteers
- 130 people
- Sponsor
- Aswan University Hospital
IUD Insertion Complication, Acute Pain
LI4 Acupuncture for Analgesia in Intrauterine Device Insertion
Pain during IUD insertion is substantially psychologic in origin, responds extremely well to non-pharmacologic interventions. Considering the fact that acupuncture is a modality exerting both psychologic and physiologic effects…
- Trial name
- NCT04963582
- Testing
- Acupuncture
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Nigde Omer Halisdemir University
Brachial Access, Access Complication
Evaluation of Shoulder Access Safety Using the NewMan Compression Device
The aim of the study is to evaluate the effectiveness of the NewMan compression device in shoulder access in patients with occlusive lesions of the femoral-popliteal segment of the lower extremity arteries by comparing the…
- Conditions
- Brachial Access, Access Complication, Hemostasis Compression Device, Atherosclerosis of the Arteries of the Lower Extremities
- Trial name
- SAND (NCT07714824)
- Testing
- Hemostasis is performed using a pressure bandage, Hemostasis is performed using the NewMan compression device
- Where
- Russia
- Volunteers
- 229 people
- Sponsor
- Pirogov Russian National Research Medical University
Vascular Access Complication, Vascular Access Device Complications
Midline Catheters Versus Peripheral Catheters in Internal Medicine Unit
The study aims to evaluate the rate of complications and the duration of cannulation of a midline intravenous catheter compared to a short peripheral catheter in patients hospitalized in an Internal Medicine service of a Spanish…
- Trial name
- NCT05512117
- Testing
- Midline insertion
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Hospital General Universitario de Valencia
Hemorrhagic Complications, Hematoma
Safety and Efficiency of the PacePress to Prevent Hemorrhagic Complications in Patients Undergoing CIED Implantation.
PacePress medical device, by ensuring constant compression force and the ability to optimize it in the pocket area prevents/significantly reduces the risk of hemorrhagic complications, including but not limited to the operation…
- Conditions
- Hemorrhagic Complications, Hematoma, Hemorrhage, Pathologic Processes
- Trial name
- PacePress (NCT05292326)
- Testing
- PacePress, standard compression band
- Where
- 7 sites in Poland
- Volunteers
- 122 people
- Sponsor
- Medinice S.A.
Intrauterine Contraceptive Device Complication
Uterine Artery Doppler and Menstrual Changes After Insertion Intrauterine Contraceptive Device
To evaluate the correlation between uterine artery Doppler indices and subsequent menstrual changes after 3 months of insertion of copper T-380 IUD and LNG-IUS
- Trial name
- NCT05986344
- Testing
- Copper intrauterine contraceptive device, LNG-IUS
- Where
- Egypt
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Beni-Suef University
Urinary Incontinence,Stress
Nationwide Observation Study to Evaluate the Efficacy and Tolerance of the Adjustable Medical Device REMEEX® in the Treatment of Male Stress Urinary Incontinence
We wish to set up a multicentric prospective observational study across France to collate data on the efficacy and tolerance of the Male REMEEX® device in patients with moderate stress urinary incontinence following radical…
- Trial name
- Remeex (NCT03650244)
- Testing
- REMEEX implantation
- Where
- 10 sites in France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Airway Complication of Anesthesia
The Effect of a Head Elevated Positioning Device on Position, Height and Depth of the Cricothyroid Membrane in Morbidly Obese Pregnant Women in the Third Trimester.
The cricothyroid membrane (CTM) is situated in the anterior neck and may be readily palpated in most people. In the event of difficulties securing the airway during a general anesthetic the CTM can facilitate emergency access to…
- Trial name
- NCT04569539
- Testing
- Ultrasound
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Premature Birth
Use of Dynamic Elastometric Body in Preterm Newborns
The goal of this prospective pilot study is to test the use of dynamic elastomeric body in a population of preterm newborns with hyperexcitability syndrome.
- Trial name
- BODYNEO (NCT05835765)
- Testing
- Dynamic Elastometric Body in Preterm Newborns
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Infertility, Abortion, Spontaneous
Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
The main objective of this study is to describe the level of expression of the biological factors involved in the formation of adhesions (Transforming growth factor beta, Activin A, inhibin) at the time of a first diagnostic…
- Conditions
- Infertility, Abortion, Spontaneous, Embryo Implantation, Delayed
- Trial name
- PréSynUT-1 (NCT02328742)
- Testing
- Hysteroscopy + endometrial biopsy, Telephone call, Resection + endometrial biopsy
- Where
- 3 sites in France
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Diabetic Retinopathy (DR), Diabete Mellitus
Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus
The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.
- Conditions
- Diabetic Retinopathy (DR), Diabete Mellitus, Fundus Photography
- Trial name
- SAFE-DM (NCT07378956)
- Testing
- VUNO Med®-Fundus AI™
- Where
- South Korea
- Volunteers
- 340 people
- Sponsor
- VUNO Inc.
Vascular Closure
Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device
The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual…
- Trial name
- NCT00842179
- Where
- United States
- Volunteers
- 2,517 people
- Sponsor
- Clinyx, LLC
Diabetic Foot Ulcer
Assessment of the Efficacy and Safety of a New Medical Device in the Local Treatment of Diabetic Foot Ulcers
Evaluation of the efficacy and safety of a device with LU3103209 compound versus the same device, free of LU3103209 compound, in the local management of DFUs.
- Trial name
- DISCOVERY (NCT03110796)
- Testing
- Dressing with LU3103209 - Dose 1, Dressing with LU3103209 - Dose 2, Dressing without LU3103209
- Where
- 6 sites in Czechia, France and 4 more
- Volunteers
- 210 people
- Sponsor
- Laboratoires URGO
Malocclusion, Orthodontic Appliance Complication
Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device
Thermoplastic devices are used in orthodontic treatment and consists of a series of nearly invisible, removable aligners. However, every device used in the mouth can change the buccal flora and increase the number of bacterias.
- Trial name
- NCT02427763
- Testing
- hours of use (Essix), collect saliva, collect biofilm
- Where
- Brazil
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Universidade Positivo
Diabetes Mellitus, Dysglycemia
The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes.
The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients.
- Conditions
- Diabetes Mellitus, Dysglycemia, Perioperative Complication
- Trial name
- WARD-glucose (NCT06314061)
- Testing
- Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
- Where
- 3 sites in Denmark
- Volunteers
- 200 people
- Sponsor
- Christian S. Meyhoff