TARIS Biomedical® has initiated a second Phase 2 study investigating LiRIS in women with Interstitial Cystitis. LiRIS is designed to continuously provide lidocaine over an extended period in the bladder. You may be able to participate! The study is currently active at 13 study centers across the United States and one in Canada, and will ultimately include up of 20 study centers in the US and Canada.
Patients who qualify and choose to participate will have the option to receive the system with lidocaine, as described as below. The study is being conducted in two parts. In the first portion, patients who qualify and choose to participate will be randomly assigned to be treated with either the active LiRIS system or a placebo system (1:1 assignment). If they qualify, patients completing this portion of the study can continue to the second part of the study, in which all participants will receive the active LiRIS system.
LiRIS is an investigational product which combines the local anesthetic lidocaine with a small, flexible delivery device. LiRIS is inserted into the bladder via a cystoscope, and remains in the bladder for 14 days where it is designed to continuously deliver lidocaine. At the end of this period, LiRIS is removed via a second cystoscopic procedure. Study participants will need to go to the clinic for study visits and assessments, and will complete questionnaires, including a voiding frequency diary, both at home during the study and during a 4 week follow-up period thereafter.
You may be eligible if you:
- Are a woman age 18 or over
- Have been diagnosed with IC
- Experience pain and voiding symptoms associated with your IC
- Are able and willing to complete the questionnaires and diary
- Can comply with the full visit schedule
Research centers are available throughout the USA:
California, Glendora – Citrus Valley Medical Research, Inc. – Contact: Lisa Regan 626-914-3295 or Robin Metzger 626-914-3295
Florida, Daytona Beach – Atlantic Urological Associates – Contact: Jonelle Horsley 386-239-8535
Indiana, Jeffersonville – First Urology – Contact: Christina Dallas 812-206-8164
Michigan, Grand Rapids – Female Pelvic Medicine & Urogynecology – Contact: Beth Rogers 588-616-1135
Michigan, Royal Oak – William Beaumont Hospital – Contact: Maureen Cooney, RN 248-551-9477
New York, New Hyde Park – Arthur Smith Institute for Urology – Contact: Monica Johnson 516-734-8515
New York, Rochester – University of Rochester – Contact: Betty Smith 585-275-2486
North Carolina, Greensboro – Alliance Urology Specialists, PA – Contact: Michelle Utrera 336-232-5322
North Carolina, Winston-Salem – Wake Forest Baptist Health – Contact: Janet Shuping 336-716-2612
Ohio, Cincinnati – The Urology Group – Contact: Pam Ervin 513-841-7550
Ohio, Cleveland – MetroHealth Medical Center – Contact: Anna McGrail 216-778-8432 or Marilyn Alejandro-Rodriquez 216-778-8432
Oklahoma, Tulsa – Urologic Specialists of Oklahoma – Contact: Susan Sossamon 918-392-2196
South Carolina, Myrtle Beach – Carolina Urologic Research Center – Contact: Jennifer Baiden 843-449-1010 ext 237
Washington, Mountlake Terrace – Integrity Medical Research – Contact: Anna Fierro 425-275-0680
[break] [hr] [break]Research centers are available throughout CANADA:
Ontario, Kingston – Centre for Applied Urological Research – Contact: Sylvia Robb 613-548-7800
[break] [hr] [break]Additional Information:
In addition to the centers listed above, we are working aggressively to expand the study at additional sites in the US and Canada. If you are interested but do not see a center near you, please check back again soon.
For more details: Please go to www.clinicaltrials.gov for more information and site locations near you. Use trial identifier NCT01824303.
Contact: Victoria Fox, (781) 676-7750 ext 250, vfox@tarisbio.com
