Clinical trial NCT01862601: JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: American Medical Systems
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2013-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety of the JetTouch system to deliver saline into the bladder wall.
timeFrame: within 14 days of the JetTouch procedure
measure: Ability of the JetTouch system to deliver saline into the bladder wall.
timeFrame: At the JetTouch procedure
Secondary outcomes:
measure: Physician feedback on the use of the JetTouch system.
timeFrame: At the JetTouch Procedure
measure: Physician feedback on perceived subject tolerability of the JetTouch injection procedure.
timeFrame: At the JetTouch procedure.
measure: Subject feedback question regarding the procedure.
timeFrame: At the JetTouch procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's Hospital / Quintiles, Ltd.
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: Consultant Urological Surgeon, Royal Hallamshire Hospital
name: Christopher R Chapple, BSc MD DHC FRCS (Urol) FEBU
role: PRINCIPAL_INVESTIGATOR
References: