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

American Medical Systems2 sites in 1 country20 target enrollmentSeptember 2013

ConditionsHealthy Subjects

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Subjects
Sponsor: American Medical Systems
Enrollment: 20
Locations: 2
Primary Endpoint: Safety of the JetTouch system to deliver saline into the bladder wall.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

March 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

American Medical Systems

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Safety of the JetTouch system to deliver saline into the bladder wall.

Time Frame: within 14 days of the JetTouch procedure

Ability of the JetTouch system to deliver saline into the bladder wall.

Time Frame: At the JetTouch procedure

Secondary Outcomes

Subject feedback question regarding the procedure.(At the JetTouch procedure)
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.)