JetTouch Injection System to deliver saline into bladder wall-healthy.
Research type
Research Study
Full title
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
IRAS ID
125670
Contact name
Christopher Chapple
Contact email
Sponsor organisation
American Medical Systems, Inc.
Clinicaltrials.gov Identifier
Research summary
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.
There will be up to 20 healthy volunteers (male or female subjects) aged 18-55 participating in this research study and their total involvement will last approximately 6 weeks. Volunteers will have no history of problems with their urinary tract or any history of chronic urine infections. Volunteers will also be screened to rule out any blood clotting abnormalities. There will be 2 clinical sites involved in the study; Quintiles at Guy’s Hospital together with Guy’s Urology Centre and also Sheffield Teaching Hospital.
The study consists of 4 visits. Visit 1 is a screening visit which includes informed consent, urine samples to check for blood and infection and a blood test to rule out any clotting problems all performed within 30 days of the procedure. Visit 2 will involve the procedure where three jet injections of a saline solution (salt water) mixed with a dye will be made into the bladder using the JetTouch system. Video recordings of the procedure will also be made by the doctor performing the procedure. Subjects will then be allowed to go home about 4 hours after the procedure. Visit 3 is about 24 hours after the procedure and will involve a visit to the clinical site or a telephone call to check up on subjects. Visit 4 will be a visit to the clinical site about 2 weeks after the procedure for a final follow up.
REC name
London - Stanmore Research Ethics Committee
REC reference
13/LO/1000
Date of REC Opinion
9 Sep 2013
REC opinion
Further Information Favourable Opinion