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 urethroplastys 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 surgerys 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 Parkinsons Disease PD who have swallowing difficulties and drooling problems. This study focuses on improving the devices 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 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 devices 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 patients with symptomatic mitral valve disease, including mitral regurgitation, mitral stenosis, and mixed mitral valve disease. This observational registry aims to improve understanding of the effects of correcting symptomatic mitral valve disease on patient outcomes, particularly in those who may be candidates for Transcatheter Mitral Valve Replacement TMVR. The data may also support future regulatory or reimbursement decisions related to the Cephea Mitral Valve System. Participants include patients with symptomatic mitral valve disease who could be considered for transcatheter mitral valve replacement, based on evaluation by a specialized heart team. The study records information without assigning treatments, focusing on those judged more suitable for TMVR than conventional surgery or other therapies like transcatheter edge-to-edge repair TEER. There are no specific interventions administered as this is an observational registry. Participants provide informed consent and agree to follow study requirements, allowing ongoing data collection during their clinical care. The study monitors patients from enrollment through up to two years of follow-up to assess clinical outcomes related to mitral valve disease management. Data collected includes health status, treatment decisions, and other relevant clinical information to better understand the impact of TMVR candidacy on patient 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 Chinas 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 pharyngeallaryngeal 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.

Researchers are evaluating the safety and effectiveness of different anti-inflammatory treatments in patients with coronary heart disease who have recurrent in-stent restenosis RISR, a condition where arteries narrow again after stent placement. This prospective, randomized, open-label trial compares standard drug therapy alone to standard therapy combined with low-dose colchicine or prednisone. The study aims to provide new strategies for managing RISR and is conducted at a single center in China with 252 planned participants. Participants are randomly assigned to one of three groups standard drug therapy including dual antiplatelet therapy aspirin plus a P2Y12 receptor antagonist, lipid-lowering drugs, and other necessary medications standard drugs plus low-dose colchicine 0.5 mg daily or standard drugs plus prednisone starting at 0.5 mgkg daily with a gradual dose reduction over one year. Treatments are oral and follow the specific dosing schedules, with colchicine started within 48 hours after intervention. Prednisone dosage is tapered monthly and maintained for one year after percutaneous coronary intervention PCI. During the 12-month study period, participants will be monitored for target lesion in-stent restenosis using coronary angiography, with major adverse cardiovascular events MACE such as death, heart attack, stroke, and revascularization also tracked. Safety is assessed by recording adverse reactions to colchicine and prednisone, including medication discontinuation due to side effects. Follow-up includes clinical evaluation and adherence monitoring to understand the impact of these therapies on RISR management. The total participation duration is one year post-randomization.