LiRIS Study Opens Across the US and Canada
TARIS Biomedical’s new investigational product LiRIS, a device that delivers lidocaine to IC patient’s bladders, is now being tested in a phase 2 study, and you may be able to participate. Open now at 12 study centers across the United States and Canada, the study will ultimately include a total of 25 centers.
The study is being conducted in two portions—first a randomized portion where patients are randomly assigned to one of three treatment arms followed by an Open Label portion where all patients who qualify and chose to participate will receive the active treatment LiRIS device. During the Randomized portion, patients will be randomly assigned to one of three treatments: having LiRIS containing lidocaine inserted in the bladder (45 percent of patients), getting a LiRIS Placebo device (no lidocaine) inserted (45 percent of patients), or having a sham procedure—a cystoscopy that would be used to insert the device, but with no device put into the bladder (10 percent of patients). The study is double-blind; that is, neither doctors nor patients know who is getting what, except for the sham procedure, when the doctor, but not the patient, will know.
The device will stay in the bladder for 14 days and then be removed, and you will need to answer the questionnaires and complete the voiding diary at various times during the study and for the four-week follow-up.
You may be eligible if you:
- Are a woman age 18 or over
- Have been diagnosed with IC (as defined by the study protocol)
- Are able and willing to complete the questionnaires and diary
- Can comply with the visit schedule, including the day 14 removal visit
- Complete the blinded study before enrolling in the unblinded part (extension) of the study
Suellen White, (781) 676-7750 ext 226, firstname.lastname@example.org
Kristin Neff, (781) 676-7750 ext 261, email@example.com
Get more details and find a study site near you:
Go to www.clinicaltrials.gov. Use trial identifier NCT01475253.
Posted January 19, 2012