Stenosis

It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Many data about these procedures exist, although most of the publications about urethroplasty are retrospective and involve a tremendous risk of bias. To address these issues, this study is designed to prospectively gain evidence about this matter in all patient subgroups facing a potential treatment with urethroplasty: native men, native women, transmen, transwomen and children.

The project goal is the development and early stage validation of a wearable sensor for dysphagia in patients with PD. The first phase of the program involves engineering goals relating to increasing the battery life of this sensor to 48 hours between charges and reducing the overall form factor size. The second phase of the program is to conduct focus groups with PD patients to assess sensor usability, set up burden, and design feedback. The third phase of the study will assess the feasibility of the sensor to detect and cue swallowing in a small cohort of PD patients.

The investigators conduct this phase II study to evaluate safety and effectiveness of EGCG in patients with dysphagia. Swallowing-related dysphagia and pain scores were recorded using the numerical rating scale (NRS) daily . Barium meal radiography was utilized to measure the luminal size and the length of the lesion area both before and after a week of EGCG treatment. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.

To compare the incidence of the composite endpoints of non-fatal ischaemic stroke, transient ischaemia (TIA) and all-cause mortality at 12-month follow-up after implantation of Bridge for the treatment of symptomatic vertebral artery stenosis in subjects who had been taking different durations of dual-antiplatelet therapy (3 vs 6 months) and ticagrelor monotherapy.

The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from December 2022 to December 2030 with 1000 subjects recruited in around 50 Chinese centers. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, operation date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary outcome was a composite of stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.

This is a prospective, multi-center, randomized trial designed to investigate the efficacy and safety of Sperstent® peripheral spot stent system versus Everflex® self-expanding peripheral stent system in the endovascular treatment of post-balloon angioplasty (post-PTA) residual lesions including stenoses and/or dissections in femoral and proximal popliteal arteries.

The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.

Background: Dysphagia was shown to be the main driver of adverse quality of life after head and neck radiotherapy. Over the 7-week radiotherapy course, patients with head and neck cancers undergo significant anatomical changes, including weight loss and tumor shrinkage (with complete response at mid-treatment in as high as 50% of patients). The current standard of care is to maintain the same radiotherapy plan for the entire treatment duration, unless major dosimetric deviations are detected. The use of MRI for treatment adaptation has the advantage of increased soft tissue contrast and is being integrated into several clinical practises with the recent development of MR-Linac technology. However, there is currently no demonstrated clinical advantage from the use of MRI for treatment adaptation in head and neck cancer. Primary objective: To compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care. Methods: This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. Patients with contra-indications to MRI will be excluded. The study will use a 2-sided, independent-sample t-test with an alpha level of 0.05 and power of 80%, with a 1:1 randomization between the 2 arms. In order to detect a 10-point improvement in the MD Anderson Dysphagia Index (MDADI) and assuming that the quality of life scores would be normally distributed with a standard deviation of 18, a total of 104 patients will be required (52 in each arm), which has been increased to 120 patients overall (60 patients in each arm) to account for a 10% dropout rate in completion of the quality of life scoring at 6 months post-treatment. An independent DSMB will review the pooled standard deviation of the interim data collected for this trial after 40 patients overall have been recruited (20 in each arm) the value of the standard deviation used to calculate the sample size required. The DSMB will inform the study team if there is potential to reduce the sample size if the standard deviation was much lower than 18 (i.e. \<=15 would result in a reduction of 25% in patients required), which will potential reduce the length of the trial. Patients will be stratified by institution and recruited in blocks of 4 to ensure a balance between arms at the interim assessment.

There are two categories of esophageal stricture in children: acquired and congenital. The development of benign esophageal stricture is based on significant fibromuscular alterations, inflammation in residual muscle layers and a deposition of collagen based on an inflammatory process . In children, these changes are most common in the context of a postoperative anastomotic stenosis in the case of esophageal atresia (usually type IIIb according to Vogt), as well as after caustic injury, peptic stricture and eosinophilic esophagitis. Rarely, children are born with congenital esophageal stricture. Therapeutic radiation can lead to stenoses requiring dilation. Likewise, children suffering from epidermolysis bullosa can suffer from esophageal stenosis. In rare cases, the ingestion of a foreign body in children causes symptomatic stenosis as a buried foreign body covered by esophageal hyper granulated tissue. Malignant stenosis is not considered in this study, as its treatment is different. There are different options for endoscopic esophageal dilations of clinically relevant esophageal strictures, which promise effective treatment. Relevant strictures are usually noticed by dysphagia. One possible dilation method uses the Savary-Gilliard bougies. These are wire-guided polyvinyl dilators. The advancement of the wire is performed under radiological fluoroscopy. Once the guide wire is placed into the stomach, the dilator is passed over the guidewire, lubricated, and pushed over the stenosis in order to dilate the stenotic area. There are also non-guidewire bougie dilators. Longitudinal shearing force and radial force occurs when the dilator passes across the stenotic area. Initially, the size of the dilator that corresponds to the diameter of the stenosis is used. The same procedure is then followed stepwise with a larger dilator of 1mm, respectively. It is generally recommended not to increase the dilator size more than 3mm in a single session. A major disadvantage of this method is the exclusively tactile control of the dilation. At the end of the Bougie dilation, the result should be checked by reinserting the endoscope to rule out deeper mucosal injuries and persistent bleeding. Furthermore, there is experience in the treatment of esophageal stenosis in children with balloon dilations. The balloon is inserted either blind or under endoscopic control, The balloon is then mostly inflated to 1 mm beyond the estimated stenosis diameter and the pressure is maintained for 1 minute or less. The dilation may be controlled radiologically or endoscopically. A dilation up to 5mm above the initial stricture diameter may not increase the risk of perforation. Only radial forces arise. Here, too, insufficient visual control is to be criticized. In particular, the distal area of the stenosis cannot be viewed during the procedure, or only with difficulty. In addition to the poor visual control, there is no tactile control of the dilation, since the volume of liquid applied to the balloon determines the diameter. Furthermore, there is no standard protocol for the stepwise dilation that is required for treating children at different ages. Finally, small esophageal balloons specifically for small children are missing, which is why balloon catheters from other areas and indications are used (e.g. urological balloon catheters, biliary catheters), respectively. Due to the severely restricted visual control of the dilation with the current dilation techniques, a conical cap made of transparent plastic was developed that can be attached to the tip of standard endoscopes, the BougieCap (Ovesco, Tübingen). The cap is a single-use product, available in different outer diameters (7- 16mm) and offers direct visual and tactile control upon introduction into the upper gastrointestinal tract under visual and tactile control. The advantage of this technique is that the endoscope acts as a carrier of the radial and longitudinal force vectors for the dilation. A comparable technique is one with the optical dilator, a clear, over-the-scope bougie with sequential dilating segments. However, the limitation of this optical dilator is that it can only be used for the dilation of relatively large stenoses (from 15mm) due to the large diameter. A main reason why the optical dilator is not suitable for children. There are currently no studies in the literature investigating the use of the BougieCap technique for treating benign esophageal strictures in children. The aim of this randomized controlled pilot study is to demonstrate the probable efficacy of the BougieCap technique, the improvement of patient and operator dependent conditions and the absence or reduction of related adverse events such as perforations, bleeding, infections as well as the number of dilation sessions and intervals, compared to the above mentioned other techniques. The BougieCap is an endoscopic attachment cap for bougienage/dilatation of stenoses and strictures of the upper gastrointestinal tract. No specific restrictions based on age, weight, health status or ethnicity. The decision on whether a patient is eligible for treatment with the product lies solely with the intended user. The BougieCap Ovesco is a medical device primarily composed of the cap and the adhesive tape that may come into contact with tissues (mainly Oesophagus mucosa) or bodily fluids (salive) during its application. As per regulatory standards, it\&#39;s crucial to note that this device does not contain pharmaceuticals, human or animal tissues, their derivatives, or any other biologically active substances.

The purpose of this two-way cohort study was to explore whether an integrated prenatal and postnatal treatment model for neonates with critical congenital heart disease (CCHD) could be effective in avoiding preoperative morbidities, creating an ideal timing for surgery, thereby reducing postoperative in-hospital mortality, and improving surgical prognosis compared with the traditional model of care. In addition, in neonates with CCHD associated with the right cardiac system, the investigators aim to further investigate whether early postnatal cardiac surgery has the potential advantage of obtaining a time window for myocardial regeneration and thus improving myocardial remodeling. The aim of this study is to improve the diagnostic and therapeutic capacity of critical congenital heart disease and to promote the integrated prenatal-postnatal treatment model for clinical use. This will ultimately improve the quality of healthcare services for patients with cardiovascular diseases and lay the foundation for exploring guidelines for the treatment of cardiovascular diseases suitable for China's national conditions. The project will be jointly implemented by Beijing Anzhen Hospital , Capital Pediatric Research Institute, and 307 PLA General Hospital. Starting from January 1, 2022, the hospitals will continue to collect hospitalized cases of newborns with CCHD. The integrated prenatal and postnatal model is defined as a definitive diagnosis of CCHD in the fetal period (22-26 weeks), documentation of intrauterine transfer in our obstetrics department, subsequent initiation of an intrapartum or postpartum surgical plan after multidisciplinary consultation, and transfer to the pediatric heart center at the first hour of life, where the child is treated with either postpartum immediate or elective surgery, depending on patient status. For neonates who meet the indications for emergency surgery, surgery is performed immediately after birth. For neonates with non-emergency surgical indications, surgery is performed after birth adjustment to optimal status. The traditional model was defined as postpartum transfer via an outside hospital with routine interventions. The investigators then evaluate surgical prognosis and myocardial regenerative capacity to compare the effects of the two treatment models. This project will validate the advantages of an integrated prenatal and postnatal model over traditional models through real-world research and will improve prognosis in neonates with CCHD.