Status:
COMPLETED
JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers
Lead Sponsor:
American Medical Systems
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 I...
Eligibility Criteria
Inclusion
- Healthy individuals (male and female) aged 18-55 without urinary complaints or documented urinary tract dysfunctions.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01862601
Start Date
September 1 2013
End Date
March 1 2014
Last Update
June 2 2014
Active Locations (2)
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1
Guy's Hospital / Quintiles, Ltd.
London, United Kingdom, SE1 9RT
2
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom