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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01862601

Enrollment

Registered

2013-05-24

Start date

2013-09-30

Completion date

2014-03-31

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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.

Interventions

DEVICEJetTouch Needle-free injection system

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026