Clinical trials: Medical Device Complication
Vascular Access Complication
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01943474
- Testing
- AccuCath IV Catheter Device, Conventional IV Catheter Device
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- C. R. Bard
Transgenderism, Erectile Dysfunction
Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons
This study aims to explore sexual satisfaction among transgender men and their partners following the placement of erectile prostheses after phalloplasty.
- Conditions
- Transgenderism, Erectile Dysfunction, Prosthesis Durability, Gender Dysphoria
- Trial name
- NCT06639776
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- University Hospital, Ghent
Implant Complication, Contraceptive Device; Complications
Improvement of Symptoms After Removal of the Essure® Contraceptive Implant
ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy.
- Trial name
- ABLES (NCT06355713)
- Testing
- Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination, blood sample, urine collection
- Where
- 10 sites in France
- Volunteers
- 444 people
- Sponsor
- Hospices Civils de Lyon
Kidney Stones, Urolithiasis
DISON I - Directly Integrated Suction and Optics System for the Treatment of Nephrolithiasis
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational device during retrograde intrarenal surgery for the treatment of renal calculi.
- Conditions
- Kidney Stones, Urolithiasis, Nephrolithiasis
- Trial name
- DISON I (NCT07712861)
- Testing
- RIRS with Investigational Device
- Where
- 5 sites in Argentina, Canada and 3 more
- Volunteers
- 75 people
- Sponsor
- Ventaris Surgical Incorporated
Non-healing Wound, Diabetic Foot
AMNIODERM+ Medical Device Clinical Study
This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC.
- Trial name
- AMNIODERM+ (NCT06442865)
- Testing
- AMNIODERM+
- Where
- Slovakia
- Volunteers
- 20 people
- Sponsor
- BioHealing s.r.o.
Catheter Complications
Clinical Pharmacy for Patients with a PICC Line
Clinical pharmacy is a patient-centered discipline and improves significantly the safety of drug management. Regarding medications, clinical pharmacy is efficient.
- Trial name
- CLIPICC (NCT04359056)
- Testing
- Clinical pharmacy activities along the care pathways
- Where
- France
- Volunteers
- 138 people
- Sponsor
- University Hospital, Toulouse
Vascular Access Complication
Ultrasound vs Veinviewer in Patients With Difficulty IV Access
Patients with difficulty intravenous access frequently have delay of care in emergency departments because Emergency Department (ED) personnel could not establish intravenous (IV) access for diagnostic blood test or treatment.
- Trial name
- NCT02618252
- Testing
- Zonare, Veinviewer
- Where
- United States
- Sponsor
- University of Maryland, Baltimore
Acute Kidney Failure, Chronic Kidney Diseases
Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients
To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin.
- Trial name
- NCT06358365
- Testing
- The AquaPass System
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- AquaPass Medical Ltd.
Bacterial Vaginosis
A Study of the New Medical Device Polybactum®
The POLARIS trial is designed as a multicenter, open label, non-comparative, 3 months, clinical study. Interventional, non-controlled, multicenter trial with a prospective design on one cohort of patients
- Trial name
- POLARIS (NCT02863536)
- Testing
- Polybactum®
- Where
- Romania
- Volunteers
- 56 people
- Sponsor
- Effik Italia S.p.A.
Dialysis; Complications, Vascular Access Complication
Access Cannulation Trial II
This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating…
- Trial name
- ACT II (NCT05490225)
- Testing
- VenaSure
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Voyager Biomedical
Preterm Birth, Blood Transfusion Complication
Blood Warming in Preterm Infants to Decrease Hypothermia
Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia.
- Conditions
- Preterm Birth, Blood Transfusion Complication, Hypothermia
- Trial name
- NCT05170633
- Testing
- Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
In this research study we want to learn more about a study drug, tetrasodium sodium EDTA (Kitelock™) for maintaining the patency (blood flow) through a central venous catheter.
- Trial name
- NCT04559334
- Testing
- Tetrasodium EDTA Catheter Lock Solution
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Children's Hospital
Device Related Infection, Vascular Access Complication
The IVCare Adaptive Platform Trial
The IVCare trial is a multicentre adaptive platform study evaluating interventions to prevent infections and other complications associated with central venous access devices (CVADs) in patients with newly inserted or existing…
- Conditions
- Device Related Infection, Vascular Access Complication, Device Related Sepsis, Catheter Infection
- Trial name
- NCT07587593
- Testing
- Connectors/Caps Domain - Standard of Care, Curos™, ClearGuard™ HD
- Volunteers
- 2,500 people
- Sponsor
- The University of Queensland
Bariatric Surgery, Complication
Safety and Feasibility of Endomina, an Candy Cane Syndrome Endoluminal Suturing Device
Surgery is currently the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary pancreatic deviation and duodenal switch) or a…
- Trial name
- Endomina (NCT03608267)
- Testing
- Endomina
- Where
- 2 sites in Belgium
- Volunteers
- 4 people
- Sponsor
- Erasme University Hospital
Sedation Complication
Validation of a Processed EEG Device for Monitoring Sedation in PICU
The goal of this prospective observational study is to validate pEEG as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs.
- Trial name
- NCT05969483
- Testing
- pEEG monitoring
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Azienda Ospedaliera di Padova
Aortoiliac Occlusive Disease, Stent Complication
BS-CERAB TECHNIQUE
The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way.
- Conditions
- Aortoiliac Occlusive Disease, Stent Complication, Vascular Device Occlusion, Iliac Artery Stenosis
- Trial name
- BS-CERAB (NCT06012123)
- Testing
- Aortoiliac angioplasty and stenting
- Where
- Spain
- Volunteers
- 21 people
- Sponsor
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Appropriate Affect, Complication of Device Insertion
Requirements of Propofol With Target Controlled Infusions for Supraglottic Airway Devices
to evaluate and compare the effect-site concentration of propofol with the TCI system for second-generation SGA device insertion between the I-gel™, Supreme™, ProSeal™ and Laryngeal Tube Suction II™.
- Trial name
- NCT04664595
- Testing
- Propofol Fresenius
- Where
- 2 sites in Thailand
- Volunteers
- 40 people
- Sponsor
- Prince of Songkla University
Mechanical Complication of Cardiac Electronic Device
Multicenter Imaging in Lead Extraction Study
The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone…
- Trial name
- MILES (NCT03772704)
- Where
- 5 sites in United States, Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Surgery-Complications, Medical Complication
Vital Sign Monitor Device Validation - WARD
Aim: to assess the validity of CE/FDA approved vital sign monitor devices for clinical use in clinical setting. Patients: up to 1000 medical and/or surgical patients will be included Intervention: Studies with various wirless or…
- Trial name
- ViVa-WARD (NCT06106516)
- Testing
- novel vital sign monitor
- Where
- 2 sites in Denmark
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Tracheostomy, Oral Cancer
Novel Tracheostomy Tube Fixation Device in Oral Cancer Patients
This study evaluated a novel tracheostomy tube fixation device in post-tracheostomy patients with oral cancer. After tracheostomy, conventional fixation methods may be associated with skin pressure injury, wound contamination…
- Conditions
- Tracheostomy, Oral Cancer, Post-Tracheostomy Care, Tracheostomy Complications
- Trial name
- NCT07701226
- Testing
- Novel Self-Adhesive Bidirectional Tracheostomy Tube Fixation Device, Routine Tracheostomy Care and Conventional Fixation
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine