JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers

Study to Evaluate the Safety and Performance of the JetTouch Needle-Free Endoscopic Injection System to Deliver Saline Into the Bladder Wall of Healthy Subjects

This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall. The JetTouch Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected into the bladder without using a needle. It is hoped that this method will provide a reliable and consistent method to deliver drugs into the bladder wall.

Inclusion Criteria:

• Healthy individuals (male and female) aged 18-55 without urinary complaints or documented urinary tract dysfunctions.

Exclusion Criteria:

• Unable or unwilling to sign Informed Consent Form or comply with study requirements
• Non-English speaking
• Currently enrolled in another clinical trial
• Undergone treatments given into the bladder in the past 4 weeks
• Female subject and has a positive urine pregnancy test at the time of screening/procedure or intends to become pregnant while enrolled
• Female subject and is currently breast feeding
• Female subject and has given birth in past 6 months
• Current or history of chronic urinary tract infections
• Current or history of chronic hematuria
• Current or history of bladder cancer
• History of major surgery in the last 6 months
• Current or history of bleeding disorders
• Currently taking anticoagulants
• Taking aspirin and is unable to discontinue treatment for 2 weeks prior to bladder injection
• Taking NSAIDS and is unable to discontinue 48 hours prior to bladder injection
• Platelet count, prothrombin time/INR (PT/INR) and partial thromboplastin time (PTT) outside the normal limits of the laboratories established reference ranges
• Current or history of any of the following: neurogenic bladder, radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi
• Known hypersensitivity to any of the agents used in the injection (FLEXLINE-Bladder® Attachment material, lidocaine, saline, Indigo Carmine dye or Ciprofloxacin)
• Current or history of any medical condition that in the opinion of the Investigator would make them an unsuitable candidate for this study.