Stenosis

Researchers are investigating urethroplasty as a treatment option for urethral stricture disease across all patient groups, including native men, native women, transmen, transwomen, and children. This prospective observational study aims to gather unbiased evidence on urethroplasty's outcomes compared to other treatments like direct vision internal urethrotomy or dilation, which have shown lower long-term success rates. The study is sponsored by the University Hospital, Ghent, and focuses on understanding treatment effectiveness and patient experience over time. The study observes patients undergoing urethroplasty, an open reconstructive surgery designed to restore normal urine flow by repairing urethral strictures. There are no intervention groups or comparators since it is an observational study. The study tracks patient outcomes over several years to measure the surgery's success and impact on various aspects of health and quality of life. Participants will be monitored from the time of surgery up to 10 years to assess failure-free survival, meaning the time until stricture recurrence or death. Additionally, patients will complete questionnaires before surgery and at regular intervals for up to two years afterward to track changes in erectile function, ejaculatory function, urinary function, continence, and quality of life. This long-term follow-up allows researchers to understand both the clinical and personal effects of urethroplasty.

Researchers are developing and validating a wearable sensor designed to help patients with Parkinson's Disease (PD) who have swallowing difficulties and drooling problems. This study focuses on improving the device's battery life and size, assessing usability with patient feedback, and testing its ability to detect and encourage swallowing in PD patients. The aim is to provide a digital therapeutic platform that can support swallowing function in this population. The wearable device, called the Aria sensor, is a patch that monitors physiological signals continuously and provides vibratory haptic cues to increase how often participants swallow. Participants will use the sensor for three weeks, with the device actively providing haptic cues only during the second week. This single-arm study tracks how the sensor performs in real-life conditions without randomization or blinding. Participants will be involved for three weeks, during which researchers will measure swallow frequency changes, participant adherence to using the haptic cues, and changes in clinical scales related to drooling and swallowing. Assessments include comparing sensor data to a gold standard and evaluating symptom severity before and after the intervention. The study also includes focus groups to gather patient feedback on usability, and safety monitoring is conducted throughout the study period.

Researchers are evaluating the effects of different durations of dual-antiplatelet therapy (DAPT) followed by ticagrelor monotherapy in patients with symptomatic vertebral artery stenosis who have undergone Bridge implantation. The study compares the incidence of a combined outcome including non-fatal ischemic stroke, transient ischemic attack (TIA), and all-cause mortality over a 12-month follow-up period. This trial aims to determine the optimal length of DAPT to improve patient outcomes after the procedure. Participants are randomly assigned to one of two treatment groups: one group receives 3 months of dual-antiplatelet therapy followed by 9 months of ticagrelor alone, while the other group receives 6 months of dual-antiplatelet therapy followed by 6 months of ticagrelor monotherapy. The Bridge device (MicroPort NeuroTech, Shanghai, China) is implanted in all participants as part of the treatment for vertebral artery stenosis. Throughout the study, participants will be monitored regularly to assess the occurrence of stroke, TIA, mortality, bleeding events, and neurological outcomes at various time points, including 1 month and 12 months after treatment. Imaging follow-up will evaluate in-stent stenosis in a subgroup of patients. The primary outcome is measured at 12 months, and safety and efficacy are closely observed during this period. The total study duration for each participant is approximately one year.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the device's performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.

Researchers are conducting a prospective, multicenter, randomized trial to assess the effectiveness and safety of the Sperstent® peripheral spot stent system compared to the Everflex® self-expanding peripheral stent system. The study focuses on treating residual lesions such as stenoses and dissections that remain after balloon angioplasty in the femoral and proximal popliteal arteries. These conditions are common in patients with peripheral arterial disease and affect blood flow in the legs. Participants will receive either the Sperstent® peripheral spot stent system or the Everflex® self-expanding peripheral stent system during endovascular treatment following percutaneous transluminal angioplasty (PTA). Both treatments involve placing a stent to open narrowed or blocked arteries, guided by digital subtraction angiography (DSA). The trial compares these two devices to understand their impact on artery patency and safety over time. Throughout the study, participants will be closely monitored with follow-up assessments including imaging to check artery openness, clinical evaluations of symptoms using Rutherford classification and ankle-brachial index (ABI), and tracking of major adverse events. Key outcomes include primary patency at 12 months and freedom from major adverse events at 30 days after the procedure. The study period includes evaluations immediately after treatment and at 30 days, 6 months, and 12 months to monitor device success, procedural success, and changes in clinical status.

Researchers are collecting clinical data on adults with symptomatic mitral valve disease, including those with mitral regurgitation, mitral stenosis, or mixed mitral valve disease. This observational registry aims to better understand the effects of correcting mitral valve disease on health outcomes, especially for patients who might be candidates for Transcatheter Mitral Valve Replacement (TMVR). The gathered information may also help guide future regulatory decisions for the Cephea Mitral Valve System. Participants include symptomatic patients considered suitable for TMVR by their heart care team, favoring this approach over conventional surgery or other therapies. The study will follow patients from enrollment for up to two years to observe their clinical progress. There are no specific treatments or interventions assigned by the study since it is observational. During the study, participants' health data will be collected regularly to monitor their condition and outcomes related to mitral valve disease correction. Follow-up includes reviewing clinical status and treatment effects over the two-year period. Participants must consent to data collection and follow-up visits, allowing researchers to evaluate the impact of TMVR candidacy on their health over time.

Researchers are evaluating a new approach to treating patients with squamous cell carcinoma of the oropharynx who have larger primary tumors (stage T3-T4). This phase II randomized trial compares the current standard chemoradiation treatment with a new method that adapts radiotherapy based on MRI scans taken mid-treatment. The goal is to see if adjusting radiation therapy according to tumor shrinkage seen on MRI can reduce swallowing difficulties measured six months after treatment. Participants will be randomly assigned to one of two groups. The standard care group receives radiotherapy planned at the start of treatment, with adjustments only if major anatomical changes occur. The experimental group receives systematic radiation plan changes guided by mid-treatment MRI scans to target the shrinking tumor. Both groups may also receive chemotherapy as part of their treatment. This study uses advanced MR-Linac technology to enable detailed imaging during therapy. During the study, patients will undergo assessments including patient-reported swallowing function measured six months after treatment using the MD Anderson Dysphagia Inventory. Researchers will also monitor acute and late side effects for up to five years after chemoradiation. The trial includes safety monitoring and statistical review of interim data to ensure appropriate sample size. Participation involves regular clinical visits, imaging, and questionnaires to track treatment effects and quality of life.

This research aims to evaluate the safety and effectiveness of the BougieCap device for stretching narrow areas in the esophagus (food pipe) in children. The study compares the BougieCap with traditional dilation methods such as Savary-Bougie or balloon dilation. The goal is to determine if the BougieCap works better, is easier to use, and causes fewer problems or discomfort for children with benign esophageal strictures. Participants are randomly assigned to one of two groups: one group using the BougieCap attached to an endoscope that allows direct visual and tactile control during dilation, and the other group receiving standard treatment with either Savary-Bougie dilation or balloon dilation under endoscopic or radiological control. These treatments involve gradually widening the narrow esophageal areas using different techniques and sizes of dilators or balloons. During the study, participants will answer questions about their symptoms before treatment, 24 hours after, and 14 days later, either during regular hospital visits or over the phone. Researchers will monitor the success of the dilation immediately after the procedure and assess any adverse events, such as bleeding or infections. The study does not add extra risks or burdens for participants and continues until December 2026.

Researchers are investigating whether an integrated prenatal and postnatal treatment model improves outcomes for newborns with critical congenital heart disease (CCHD) compared to traditional care. This study aims to see if early diagnosis during pregnancy, combined with coordinated delivery and surgical planning, can reduce preoperative complications, optimize surgery timing, lower postoperative mortality, and enhance heart healing, especially in cases involving the right heart system. The goal is to improve treatment capacity and create guidelines suited to China's healthcare needs. The integrated model involves diagnosing CCHD by ultrasound at 22 to 26 weeks of pregnancy, transferring the mother within the hospital system before birth, and planning surgical care after multidisciplinary discussion. Newborns are transferred to the pediatric heart center immediately after birth for either urgent or elective surgery depending on their condition. Traditional care involves transferring newborns from outside hospitals with routine interventions. The study compares these two approaches by following patients from birth through surgery and afterward. Participants will be monitored during hospitalization, with evaluations of heart function, metabolic status, and survival rates over up to five years post-discharge. Researchers will assess 30-day postoperative mortality as the primary outcome and also look at heart failure before surgery, the proportion receiving integrated care, and long-term survival and reoperation rates. This real-world study uses hospital data from multiple sites to validate if the integrated prenatal-postnatal model offers better outcomes for newborns with CCHD.

Researchers are evaluating whether a behavioral health program can improve swallowing and voice outcomes in patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgery. This prospective study enrolls patients having primary ACDF surgery and aims to determine if the program helps prevent swallowing and voice difficulties six weeks after surgery. The research is conducted at NYU Langone and focuses on dysphagia, which affects swallowing ability. Participants will receive a behavioral intervention program including hydration counseling, protein supplementation, and daily pharyngeal/laryngeal exercises for seven weeks total. This begins one week before surgery and continues for six weeks afterward. Weekly 45-minute sessions with a speech-language pathologist start about one week post-surgery and last for six weeks. The study compares these patients to historical controls who had ACDF surgery but did not receive the intervention. During the study, participants will undergo swallowing assessments using videofluoroscopy before surgery and six weeks after. Acoustic voice samples and patient-reported measures for swallowing and voice will also be collected at these times. Researchers will track adherence to hydration goals via a daily log. The main outcomes measured include changes in swallowing function and voice quality from baseline to six weeks post-operation. The total study duration for each participant is seven weeks.