Catheter Complication

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.

Ureteric stents and catheters are commonly used to restore urinary drainage in patients with kidney stones or cancers pressing on the ureters. These devices often cause complications like inflammation, pain, and infections, which negatively affect quality of life and increase antibiotic use. Device-associated encrustation and biofilm formation lead to urinary tract infections in more than 90% of cases, causing stent blockages and contributing to antibiotic resistance. This research aims to study a novel ureteric stent designed to reduce these complications and improve patient outcomes, particularly in elderly and oncology patients. The trial evaluates an experimental ureteric stent with specially shaped side-holes that prevent low-flow areas where particles settle, reducing encrustation and biofilm formation. Patients with kidney stones or abdominal/pelvic cancers requiring stents will receive this novel stent instead of a conventional JJ stent. The stent will be removed after 4 weeks for kidney stone patients and after 25 weeks for oncology patients. Recruitment for the oncology group starts after reviewing kidney stone patient results. Additionally, qualitative interviews will be conducted with patients and doctors about their stent experiences. Participants will be monitored from enrolment until stent removal, with assessments of stent failure rates, extent of encrustation and biofilm, clinical outcomes, quality of life, and patient experiences. Questionnaires will be completed 2-3 weeks after stent removal. The study includes multiple visits and data collection to understand the impact of the novel stent. Researchers aim to reduce hospital admissions, improve quality of life, and decrease antibiotic use through this innovative device, with follow-up lasting up to 25 weeks for oncology patients.

Researchers are evaluating the preferred dose of lisinopril in men with non-metastatic prostate cancer who are undergoing radiation treatment. The study aims to assess how lisinopril affects urinary symptoms and biomarkers related to these symptoms during and after radiation therapy. This is an early phase 1, randomized trial sponsored by the University of Rochester. Participants will either receive radiation therapy alone or radiation combined with lisinopril tablets at escalating doses of 5 mg, 10 mg, or 20 mg taken once daily. The study compares these groups to understand the optimal lisinopril dose for preventing urinary toxicity after radiotherapy. Radiation may be given as primary, adjuvant, or salvage treatment, possibly with androgen deprivation therapy. During the 12-month study, researchers will monitor urinary symptoms using the Expanded Prostate Index Composite score and measure the presence of blood in urine. They will also track how many participants reach the 20 mg lisinopril dose. Participants will undergo assessments including blood tests and evaluations of kidney, liver, and blood function. The study includes follow-up to evaluate the safety and effects of lisinopril on urinary health after radiation treatment.

The trial investigates the safety and effectiveness of Voyager Biomedical's Access Device designed to help patients undergoing routine hemodialysis by facilitating the cannulation of arteriovenous fistulas (AVFs). This pivotal, interventional, single-arm, open-label study aims to support FDA clearance of the device by assessing its ability to improve access during dialysis and ensure patient safety. The study addresses challenges where AVFs are difficult to cannulate due to depth or accessibility issues and evaluates the device as a potential alternative to other surgical methods. Participants will have the VenaSure device surgically implanted at the dialysis access site, tailored to their clinical needs. Depending on vascular access conditions, one or two devices may be implanted to assist arterial and/or venous cannulation. After implantation, patients will be observed for 6 weeks to allow healing. Following this, they will be monitored for 36 months while undergoing routine hemodialysis to assess the device's long-term performance and safety. During the study, participants will have regular follow-up visits to monitor healing, device function, and any adverse effects. Researchers will collect data on the device's ability to facilitate cannulation at 6 months and evaluate safety outcomes at 12 months and beyond. The study lasts approximately 48 to 60 months from enrollment until data collection is complete. Patients exit the study after the final visit with no ongoing device-related safety concerns.

Researchers are evaluating two types of transparent dressings used on central venous catheters (CVCs) to prevent bloodstream infections in children admitted to a pediatric intensive care unit (PICU). This randomized, single-blind trial compares dressings impregnated with chlorhexidine gluconate to conventional transparent dressings. The study aims to understand which dressing better reduces catheter-related infections, catheter colonization, skin complications, and the frequency of dressing changes. Participants will be randomly assigned to receive either the advanced chlorhexidine gluconate-impregnated transparent dressing or the standard transparent polyurethane dressing without antimicrobial properties at the catheter insertion site. The chlorhexidine dressing provides sustained antimicrobial protection while allowing visibility of the site and may reduce the need for frequent catheter manipulation. Both dressings are applied at the central venous catheter insertion area and monitored during the study period. During the study, participants will be observed from baseline up to four weeks or until catheter removal, whichever occurs first. Researchers will track infection rates, catheter colonization at removal (up to 14 days after insertion), skin issues at the insertion site, and how often dressings need changing. The study involves careful monitoring of the catheter site and overall health while participating, with safety and infection outcomes recorded throughout the follow-up period.

Researchers are evaluating the rate of stomach migration of two types of esophageal stents used for patients with locally advanced or metastatic malignant narrowing at the gastroesophageal junction. This prospective, controlled, randomized, multicenter, single-blind study aims to compare stents with and without an anti-migration device to understand their effectiveness and safety in this condition. The study involves placing a gastroesophageal stent during digestive endoscopy under general anesthesia, guided by endoscopic and fluoroscopic control. Participants will receive either a stent with an anti-migration device (Ella®, Leufen, Novatech) or a stent without this device (Hanarostent® ECW, Life Partners Europe). This intervention is compared to assess intragastric migration and other clinical effects. Participants will be monitored for stent migration at 1, 3, and 6 months, as well as recurrence of swallowing difficulties and reflux symptoms. The study also tracks technical and clinical success of stent placement, complications like bleeding and pain, and overall dysphagia-free survival up to three years. The total participation time will vary based on individual follow-up and survival.

Researchers are evaluating the use of preventative antibiotics to reduce the risk of bladder infection after Botox injections for neurogenic overactive bladder. This condition occurs in people with neurological disorders like multiple sclerosis, Parkinson's disease, spinal cord injury, or stroke. The trial aims to determine whether giving antibiotics at the time of Botox treatment lowers the rate of postoperative urinary tract infections. This is a randomized, double-blinded study led by the University of Alberta, providing training opportunities for new researchers. Participants will be randomly assigned to receive either ciprofloxacin, an antibiotic, or a placebo pill twice daily for three days after the bladder Botox procedure. The Botox injection technique usually involves a trigone-sparing method with 200 units spread across 10 to 20 sites, but the exact method is at the physician's discretion. A urine culture is taken before the procedure to check for existing infections. During the six weeks after treatment, patients will have regular follow-ups where questionnaires will screen for urinary infection symptoms, voiding issues, or other side effects possibly related to antibiotics. Urine cultures will confirm infections if symptoms appear. The main outcome measured is the rate of urinary tract infections two weeks after the procedure, with additional assessments at one and six weeks. The study also monitors other adverse events during this time.

Researchers are evaluating the impact of Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) compared to conventional abdominal laparoscopy (CAL) for benign adnexal surgery in women aged 18 to 70. The study aims to confirm that vNOTES does not negatively affect women's sexual function after surgery, addressing concerns about vaginal scarring and its effects on sexual activity. Secondary goals include assessing vNOTES efficiency, complications, and the quality of histological analysis of surgical specimens. Participants will be randomly assigned to receive either the vNOTES or CAL surgical technique for procedures such as cystectomy, oophorectomy, salpingectomy, or tubal sterilization. Both approaches involve minimally invasive surgery, with vNOTES using the vaginal route and CAL using abdominal laparoscopy. The study also examines pain, hospital stay length, patient satisfaction, and surgical complications during and up to 30 days after surgery. Women in the study will complete questionnaires before surgery and at 3 and 6 months afterward to assess sexual function, couple satisfaction, and pain during sex. Medical and general data will be collected at enrollment, during hospitalization, and one month post-surgery. The main outcomes measured include quality of sexual life and postoperative recovery, while monitoring safety and the effectiveness of both surgical methods throughout the study period.

Researchers are investigating the prevalence and detection of blood clots related to central venous catheters (CVCs) using a new high-resolution imaging technique called photon-counting computed tomography (CT). This study aims to compare the accuracy of photon-counting CT to clinical autopsies in diagnosing subclinical CVC-related thromboses. The research focuses on both deceased patients undergoing autopsy and living patients who have CVCs and are referred for CT scans without contrast. The study consists of two parts. In the first, deceased patients with CVCs referred for autopsy will receive a photon-counting CT scan focused on the vein with the catheter, followed by a full clinical autopsy. In the second part, living patients with CVCs will undergo a photon-counting CT scan around the catheter site and an ultrasound scan within 12 hours before or after the CT. The study will compare the effectiveness of photon-counting CT and ultrasound in detecting subclinical thromboses. Participants will undergo imaging assessments including photon-counting CT scans and ultrasound scans as applicable. For deceased patients, imaging is done shortly before autopsy, and results from both are compared. In living patients, ultrasound and photon-counting CT results will be analyzed to evaluate detection performance. The study measures include the incidence of thrombosis at autopsy or CT scan and the diagnostic performance of photon-counting CT and ultrasound. Participation involves consenting to imaging procedures and data analysis, with no additional treatments administered.

This research aims to evaluate the feasibility of two bedside methods to confirm the placement of central venous catheters (CVCs) and detect complications in critically ill patients. It compares intracavity electrocardiography (IC-ECG), which monitors heart electrical activity to guide catheter tip position, and thoracic point-of-care ultrasound (POCUS), which checks for pneumothorax after CVC insertion. The study is a single-center, prospective, randomized feasibility trial to improve speed and safety in CVC verification compared to standard chest X-ray. Participants needing an internal jugular vein CVC will be randomly assigned to one of three groups: CVC insertion on the left side with IC-ECG and thoracic POCUS, CVC insertion on the right side with these techniques, or standard care involving ultrasound-guided insertion with post-procedure chest X-ray only. All participants will receive a chest X-ray after the procedure to compare the new methods with standard care. Throughout the 12-month recruitment period, researchers will measure recruitment rates, protocol adherence, data completeness, technical success, and time taken to confirm catheter tip position. They will also monitor complications up to 48 hours after insertion, review ultrasound and ECG images for consistency, assess operator confidence, and evaluate how often chest X-rays might be avoided. The study will help design larger future trials to assess accuracy and cost-effectiveness of these techniques in critical care.