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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-03-31

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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JetTouch injections

Group Type EXPERIMENTAL

JetTouch Needle-free injection system

Intervention Type DEVICE

Needle-free injection system believed to provide consistent and reliable delivery of material to the bladder wall.

Interventions

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JetTouch Needle-free injection system

Needle-free injection system believed to provide consistent and reliable delivery of material to the bladder wall.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes