Catheter

Researchers are collecting detailed data on how well Teleflex's vascular access devices perform and how safe they are when used in everyday medical care. This observational registry aims to gather high-quality evidence on devices like central venous catheters, midline catheters, peripheral catheters, hemodialysis catheters, and arterial catheters, including some with antimicrobial and antithrombogenic features. The study focuses on real-world use following the devices' instructions for use to assess their safety and success. Participants in this registry will have a Teleflex vascular access device placed as part of their therapy or diagnosis. These devices range from central venous catheters to accessories used for their placement and maintenance. The study will observe and record the use of these devices without altering standard care, tracking outcomes such as successful device use and verification of catheter tip positioning. During the study, participants will be monitored for device-related adverse events within seven days after device removal. Data collection will include whether the device was successfully used without needing removal due to complications and confirmation of catheter tip location immediately after removal for certain devices. The registry aims to provide comprehensive real-world safety and performance data over the course of the study, which starts in December 2024 and extends to December 2034.

Bladder cancer is a common type of cancer, especially in men, and most cases are non-muscle invasive at diagnosis. When it progresses to muscle-invasive bladder cancer, treatment usually involves chemotherapy followed by surgery called radical cystectomy with urinary diversion. Despite surgical advances, complications after this surgery remain frequent. The role and timing of ureteric stenting during this surgery to prevent urinary leakage and obstruction is uncertain, and prior studies have shown mixed results regarding its benefits and risks. This study is a randomized trial comparing early versus late removal of ureteral JJ stents after radical cystectomy and ileal conduit formation. Participants will be assigned to either have their stents removed early, between 5 and 7 days after surgery, or late, between 4 and 6 weeks after surgery. The study aims to assess the feasibility of conducting a larger definitive trial by evaluating complication rates and other outcomes related to the timing of stent removal. Participants will be monitored for complications within 30 days, 90 days, and up to one year after surgery. The study will also track readmission rates and feasibility outcomes over one year. Researchers will collect data on surgical complications and recovery, with no blinding involved. The total duration of participation varies, with follow-up visits to assess the effects of early versus late stent removal on patient outcomes.

Researchers are developing and validating an artificial intelligence (AI) model to predict treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) who have undergone transcatheter device closure. This observational study aims to determine if combining information from demographics, lab results, health records, echocardiography, chest X-rays, and electrocardiograms can accurately assess individual risk of complications within 30 days after the procedure. The study uses retrospective clinical data from pediatric patients treated at a single center. The AI model will be trained using deep learning techniques to analyze various types of clinical data, including text and images, collected from routine care records. The study does not involve any new treatments or interventions but focuses on data integration and AI prediction methods. The primary outcome is the occurrence of procedure-related complications within 30 days after the transcatheter closure. Participants are children aged 18 years or younger who had a confirmed diagnosis of pmVSD and underwent transcatheter device closure at the study center. Researchers will review medical records to gather necessary clinical and imaging data. The study evaluates the AI model's performance in predicting complications using metrics such as precision-recall curves, sensitivity, and predictive values, all within 30 days after the procedure. The study is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, and is planned to end in June 2026.

Researchers are investigating a new method to help locate a specific vein on the forearm (the distal cephalic vein) in young children undergoing surgery. This study focuses on children under six years old having elective procedures under general anesthesia. The goal is to find a simple, reliable anatomical landmark to guide the placement of a topical anesthetic patch (EMLA) to ease venipuncture, which can be challenging due to small or hard-to-see veins in young children. Ultrasound is used as a reference standard to validate the landmark's accuracy. The study has two parts: first, ultrasound is used to map and mark the vein's course on the skin during anesthesia, and photographic documentation is collected to develop the landmark. In the second part, anesthesia staff and parents apply the landmark or an EMLA patch guided by a visual instruction, and ultrasound checks if the vein lies beneath the marked or treated area. No additional needle punctures or blood samples are taken beyond routine care. Participants contribute data at one time point during their surgery preparation. Ultrasound measurements include whether the vein is under the marked area, vein depth, diameter, and course. Data are collected securely and pseudonymized. The study involves no added risks, no additional pain, and no biological samples. The main outcome is the success rate of locating the vein within the marked or EMLA-covered area during anesthesia.

Researchers are evaluating the Methinks Stroke Suite, an AI-based imaging software, to see if it can help speed up the transfer of acute stroke patients who may need thrombectomy from local stroke centers to specialized centers. The study focuses on patients initially assessed at centers that cannot perform endovascular therapy (EVT). The main goals are to find out whether the software reduces the time to decide on patient transfer and how accurately it identifies candidates for EVT. The study compares patient care after integrating Methinks Stroke Suite into the stroke workflow with a historical group treated before its use. Patients will have a CT scan analyzed by the AI software at the local center. If the software and clinical judgment suggest thrombectomy might be needed, patients are transferred to specialized centers. If no large vessel occlusion is detected, further imaging like CT angiography may be done to reassess. This is an open-label, quasi-experimental study conducted across multiple centers in Catalonia, Spain. Participants will undergo CT scans at their local stroke center, with imaging data processed by the Methinks software. They will be followed for 90 days after their stroke to assess recovery and functional outcomes. Researchers will measure time from arrival to transfer decision, evaluate the software's accuracy in detecting large vessel occlusions, monitor treatment rates, and gather clinician feedback on using the software. Safety during patient transfers will also be tracked. The study plans to enroll about 250 patients and includes a follow-up period of 3 months after stroke.

This research aims to observe and evaluate the outcomes of endovascular treatment for acute ischemic stroke (AIS) caused by vessel blockage in the brain's anterior or posterior circulation. The study is a prospective, multicenter, observational trial designed to assess the safety and functional recovery of patients receiving this treatment in routine clinical settings. Participants receive endovascular treatment, which may include mechanical thrombectomy using devices such as stents, aspiration catheters, or combinations with intra-arterial clot-dissolving therapies. The study records these procedures as part of standard care without randomization or comparison groups since it is observational. During the study, researchers will track patients' recovery and safety outcomes through various assessments, including a primary focus on functional improvement measured by the modified Rankin scale at 90 days. Additional measures include neurological status at 24 hours and 7 days, as well as details about blood vessel reopening immediately after and during the procedure. The study intends to provide insights into real-world treatment results and safety over the follow-up period.

Researchers are evaluating two types of devices used to secure urinary catheters in critically ill patients: adhesive devices and elastic wristband-style devices. The study aims to determine which device is more effective at preventing injuries to the urethral meatus, reducing patient discomfort, and lowering the rate of catheter-associated urinary tract infections. This is an experimental, randomized trial conducted in an Intensive Care Unit setting, addressing a significant gap in clinical guidelines and nursing practices regarding catheter securement methods. Participants will be randomly assigned to use either a commercially available adhesive device or an elastic wristband device to secure their urinary catheter on the front of the thigh. The placement is carefully chosen to allow leg movement without tension on the catheter. For adhesive devices, a protective barrier spray is applied before use, while elastic bands are adjusted to minimize movement and maintain circulation. Devices will be replaced every 72 hours or earlier if needed, alternating the thigh used for securement at each change. During the study, participants will be regularly monitored for catheter-related complications such as meatal injuries, discomfort or pain (if the patient can communicate), and urinary tract infections. Researchers will collect feedback from communicative patients about their comfort and any issues experienced. The primary outcomes are measured over an average period of 10 days. This monitoring includes clinical assessments and tracking any adverse events like catheter obstruction, skin lesions, or accidental catheter dislodgement.

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation (PVI) using high power short duration (HPSD) radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation (AF). This prospective, multi-center study aims to understand the relationship between clinical and procedural factors and the success and safety of this ablation method, with a follow-up period of 12 months to monitor AF recurrence. Patients with paroxysmal or persistent AF will undergo catheter ablation using approved mapping systems and catheters. The procedure involves sedation or anesthesia, vascular access through femoral or subclavian veins, and placement of diagnostic and ablation catheters in the left atrium. Ablation is performed with a QDot Micro catheter delivering radiofrequency energy in specific modes to isolate pulmonary veins. Effectiveness of the isolation is confirmed during the procedure, and any reconnections are addressed. Post-procedure, an ECG and optional echocardiogram are done to check for complications. During the 12-month follow-up, patients will have regular assessments at 3 months including history, physical exams, ECG, and 24-hour Holter monitoring to detect arrhythmia recurrence. Additional follow-ups between 6 and 12 months help confirm freedom from arrhythmia if no symptoms are reported. Researchers will measure outcomes such as arrhythmia recurrence rates, procedural times, vein reconnection, anesthesia impact, pain perception, and fluoroscopy duration to evaluate the procedure's overall safety and efficacy.

This research aims to evaluate how well an autonomous blood drawing device works and whether it is safe. The study includes several phases, with Phase B1 being a key clinical trial to confirm that the device performs at least as well as manual blood drawing, which is important for regulatory approval. Earlier and later phases focus on improving the technology and usability, including testing non-invasive features like ultrasound detection. Participants will receive blood draws using the Venipuncture Device, which fully automates the procedure by detecting veins with near-infrared and ultrasound imaging, inserting a needle robotically, connecting blood tubes, and applying pressure to the puncture site. Depending on the phase, the device may replace or supplement manual blood draws. Some phases involve one or two automated draws, and the technology is progressively improved, with more manual steps required in early phases and fewer later on. During the study, participants will undergo standard blood drawing procedures at outpatient blood drawing departments or at a volunteer site. Researchers will measure the success rate of first-time venipuncture, the rate of punctured participants, hemolyzed samples, and adverse events over seven days. The study includes safety monitoring, and participant involvement varies by phase, with some receiving additional automated blood draws beyond routine care.

Atrial fibrillation (AF) is a common heart rhythm disorder that greatly increases the risk of stroke, heart failure, hospitalization, and death. This research aims to compare two treatment approaches for elderly AF patients who are frail and have a high risk of bleeding. The study evaluates catheter ablation combined with left atrial appendage occlusion (LAAO) against catheter ablation combined with long-term oral anticoagulation (OAC), addressing a current gap in evidence about the best strategy for this vulnerable group. Participants will be randomly assigned to one of two groups: one receiving catheter ablation plus LAAO, a device-based procedure to prevent stroke, and the other receiving catheter ablation plus standard oral anticoagulation therapy. The LAAO procedure may be done during the ablation session or separately. After LAAO, participants receive anticoagulation for 90 days, followed by possible de-escalation based on imaging results. The other group continues guideline-directed anticoagulation after ablation. Both groups are closely monitored for safety and effectiveness. During the 24-month study, participants will undergo regular assessments including ECGs, Holter monitoring to track heart rhythm, and imaging tests to evaluate heart function and device status. Researchers will measure outcomes such as stroke, bleeding events, death, AF recurrence, and quality of life. Additional evaluations include frailty scores, cognitive function, and daily living activities. The study also monitors procedural success, hospital stay length, and complications to help determine which treatment better supports elderly patients with AF.