3 Clinical Trials for Various Conditions
This clinical investigation is to evaluate the safety, performance, and efficacy of a novel endoscopic technique for resolving esophageal food impactions by using a novel hollow suction catheter, Piranha GI Aspiration Catheter, to core out and suction food away from the center of an impaction. This technique includes hollowing out the center of the impaction, thus reducing the volume of the food bolus in the center, allowing the food to collapse into the hollow center, and then allowing for spontaneous food passage into the stomach. The study design is based on the experience of the investigators and the general knowledge of the food impaction field. In addition, consideration was given to previous studies of endoscopic treatments for esophageal food impaction.
This study is designed to obtain data on the safety and efficacy of oral nitroglycerin solution for the treatment of esophageal food impaction in patients presenting to the Emergency Department with presumed esophageal food impaction. The main hypothesis is to determine the success rate of oral nitroglycerin solution in relieving the food impaction by assessing the resolution of symptoms and the ability of the patient to swallow.
This study is for patients who have had a food impaction and/or difficulty swallowing, who are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the esophagus. Standard treatment for people who have food impaction and difficulty swallowing is endoscopy to view the esophagus, tissue biopsies of the lining of the esophagus for diagnosis, and drug therapy including steroids and drugs used to treat reflux disease. Early dilatation or stretching of the esophagus may be done at this time but not always. Some doctors prefer to wait and see if the drugs are affective. It is not known if dilating the esophagus early in treatment adds benefit. Therefore, we are doing this study to compare the two methods of treatment. We will compare two groups: one group will have dilatation performed during the first endoscopy and one group will not have dilatation performed during endoscopy. We will see if dilatation helps prevent food impaction and improves swallowing. Another purpose of this study is to learn more about the causes of swallowing problems, thus extra biopsies will be taken of the esophagus and store them for future research.