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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Device: JetTouch Needle-free injection system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JetTouch injections<br> | Device: JetTouch Needle-free injection system<br>* Needle-free injection system believed to provide consistent and reliable delivery of material to the bladder wall.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the JetTouch system to deliver saline into the bladder wall. |  | within 14 days of the JetTouch procedure | 
| Ability of the JetTouch system to deliver saline into the bladder wall. |  | At the JetTouch procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician feedback on the use of the JetTouch system. |  | At the JetTouch Procedure | 
| Physician feedback on perceived subject tolerability of the JetTouch injection procedure. |  | At the JetTouch procedure. | 
| Subject feedback question regarding the procedure. |  | At the JetTouch procedure |