A pilot study of the JiffyStent ureteric stent inserter for patients with acute renal colic requiring a ureteric stent.

A common presentation the emergency department is a patient in excruciating pain from a kidney stone obstructing the ureter and kidney. Many of these patients will require a ureteric stent to relieve the obstruction and their pain. The current best treatment is to admit these patients to the operating room and insert a stent with the patient under general anaesthetic. This process can take 24 hours or more. The JiffyStent is an innovative single use medical device that allows the Urologist or Emergency Department Physician to insert a ureteric stent while the patient is in the emergency room. This is a proof of concept study to show that the JiffyStent device works as desired by correctly inserting a stent into the ureters of patients, initially under controlled conditions in the operating room, and then in the emergency department. It is anticipated that use of the device will take 3-5 mins. If a stent cannot be inserted with the JiffyStent after the first attempt, then a stent will be inserted in the operating room by the standard procedure. The outcome of every JiffyStent case and the success of the stent insertion will be recorded by the trial team by medical record review and discussion with the treating doctor. The study will involve two phases: the first is 10 patients under controlled conditions in the operating room. These are patients who require a stent as a standard part of their urological procedure; the second phase is 40 patients who present to the emergency room with acute renal colic from a kidney stone and require a ureteric stent to be inserted. A successful outcome will lead to a pivotal multicentre clinical trial necessary for regulatory approval thereby making the JiffyStent device available for widespread use.