Catheter Complication

This research aims to gather detailed, high-quality data on the performance, safety, and clinical benefits of Teleflexs vascular access devices when used in everyday medical settings. The study focuses on a range of devices including central venous access devices, midline catheters, peripheral catheters, hemodialysis catheters, arterial catheters, and tip confirmation devices, many with antimicrobial and antithrombogenic features. Participants will undergo procedures involving these Teleflex devices as needed for therapy or diagnosis. The registry tracks the use of these devices along with related accessories used for placement and maintenance, collecting data on their safety and effectiveness in real-world practice. During the study, participants device use will be monitored, including successful device use without removal due to device-related events and verification of catheter tip location. Safety is assessed through monitoring device-related adverse events within 7 days after device removal. The study runs from December 2024 to December 2034, involving data collection during and shortly after device use.

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 abdominalpelvic 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 studying men with non-metastatic prostate cancer who are receiving radiation treatment to find the preferred dose of lisinopril. The study aims to evaluate how lisinopril affects urinary symptoms and how it influences certain biomarkers related to these symptoms. This phase I trial focuses on prevention of urinary toxicity caused by radiation therapy. Participants will be given lisinopril tablets in escalating doses of 5 mg, 10 mg, and 20 mg once daily. The study includes a control group receiving radiation treatment without any intervention. The trial is randomized and sequential, allowing comparison between the groups to determine the best dose that may prevent urinary side effects after radiotherapy. During the study, participants will be monitored for changes in urinary symptoms using the Expanded Prostate Index Composite score over 12 months. Researchers will also track the percentage of patients with blood detected in urine and the proportion who tolerate the highest dose of 20 mg. The total study duration includes follow-up assessments to measure these outcomes and ensure safety, with the trial completion planned by 2028.

The trial investigates the safety and effectiveness of Voyager Biomedicals 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 andor 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 devices 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 devices 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 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, Parkinsons 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 physicians 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 womens 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.

Researchers are evaluating two methods for preparing the cervix before same-day Dilation & Evacuation D&E procedures in the second trimester of pregnancy. The trial aims to show that using a single-balloon catheter is not worse than using osmotic dilators, focusing mainly on the time it takes to complete the D&E operation. Additional goals include comparing how well each method softens the cervix, the ability to complete the procedure on the same day, participant pain levels, satisfaction, and safety. Participants are randomly assigned to one of two groups. One group receives cervical dilation through a single-balloon catheter placed transcervically, which is filled with water or saline and left in place for about 3 to 4 hours or until it naturally falls out. The other group uses synthetic osmotic dilators that swell in the cervix over 3 to 4 hours to achieve dilation. Both devices are used shortly before the D&E procedure on the same day. During the study, participants will have their dilation adequacy and pain monitored hourly until the procedure, which typically lasts about 20 minutes. Satisfaction will be assessed after dilation, and the procedures completion on the same day will be tracked over a year. Participants must be able to provide informed consent and speak English or Spanish. Safety and procedural complications will be carefully observed throughout the trial, which follows participants from preparation through the D&E procedure.

Researchers are evaluating two different vein approaches, the basilic vein and the cephalic vein, for placing midline catheters in children aged 2 to 17 years who need this device during general anesthesia. This randomized controlled trial aims to find out which vein approach leads to better blood sampling success during the catheters use. The study also looks at other factors like ease of catheter placement, number of needle attempts, vein size, catheter duration, complications, and patient satisfaction. Participants will be randomly assigned to receive midline catheter placement either through the basilic vein or the cephalic vein using ultrasound guidance. The catheter will remain in place for up to 7 days after surgery, during which several outcomes will be measured. The trial includes two groups with equal numbers of children receiving each vein approach to compare the results. During the study, doctors will assess blood sampling success by checking if at least 2 mL of blood can be drawn through the catheter at least once without needing extra needle sticks. They will also evaluate difficulty of insertion, number of punctures, vein measurements, catheter time in place, any complications, and how satisfied patients are. These evaluations will take place from the time of catheter insertion until removal, with some measurements taken up to the first day after surgery. The total participation spans from catheter insertion through up to 7 days postoperatively.