12 Clinical Trials for Various Conditions
No standard approach currently exists for endoscopic esophageal stent placement, and both sutured and un-sutured techniques are employed for esophageal stent placement currently. The primary purpose of this study is to find out if suture fixation of esophageal stents is superior to non-suture fixated stent placement. Consecutive patients who are scheduled for esophageal stent placement will be identified as potential study participants by study personnel and will be approached on the day of the procedure. Informed consent will be obtained and patients will be randomized into suture fixation and non-suture fixation groups. Patients in the suture fixation group will have their esophageal stent secured in location with two endoscopic sutures. Those in the non-suture fixation group will have no sutures placed. Main study outcome is stent migration, and rates of stent migration will be compared in the two groups.
This study aims to assess the efficacy and rate of stent migration in standard of care esophageal stents that are not fixed, compared to those that are fixed with either standard of care OTSC stentfix or standard of care stent placement with suturing in both benign and malignant esophageal strictures.
Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision.
Esophageal stents are commonly used for benign esophageal pathology, especially strictures or esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting factor to stent placement is the high migration rate of the stent. Investigators are trying to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign esophageal disease in comparison with standard, fully covered self-expanding metal stents (FCSEMS) placement without fixation.
The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.
The purpose of this study is to investigate whether OTSC stentfix is a feasible, safe, and efficient device that can be used for esophageal stent fixation (to prevent stent migration) in patients with benign, non-stricture esophageal lesions, including leaks, perforation, and fistulae. Currently, self-expandable metal stents (SEMS) have a risk of migration which can lead to adverse events such as bleeding and perforation. There has been clinical experience demonstrating that stent suturing can prevent stent migration. However, stent suturing can significantly increase endoscopic procedural time. The use of OTSC stentfix for stent fixation is promising as it is likely less time-consuming and less technically difficult, with likely a similar rate of fixation and migration. This non-inferiority study aims to investigate how OTSC stentfix functions as compared to stent suturing. If OTSC stentfix is at least comparable to stent suturing, it can reduce endoscopy procedural times, minimize peri-endoscopic risks, and minimize adverse events related to stent migration.
The purpose of this prospective registry is to assess long term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the Gastrointestinal tract for various GI tract disorders. The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.
Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.
This project is being done to compare two current treatment clinical options for management of RBES: 1) Frequent dilations followed by temporary esophageal stent placement if dilations fail, or 2) Early stent placement followed by dilations
In this study, a newly designed and FDA approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed before and after treatment to confirm efficacy
RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve quality of life in patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer. PURPOSE: This randomized clinical trial is studying self-expanding plastic stents to see how well they work compared with self-expanding metal stents in treating patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.