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

American Medical Systems

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Device: JetTouch Needle-free injection system

Study type

Interventional

Funder types

Industry

Identifiers

NCT01862601

OT1202

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.