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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

Interventions

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

Arms, Groups and Cohorts

  • Experimental: JetTouch injections

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Physician feedback on the use of the JetTouch system.
    • Time Frame: At the JetTouch Procedure
  • Physician feedback on perceived subject tolerability of the JetTouch injection procedure.
    • Time Frame: At the JetTouch procedure.
  • Subject feedback question regarding the procedure.
    • Time Frame: At the JetTouch procedure

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • American Medical Systems
  • Collaborator
    • Quintiles, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christopher R Chapple, BSc MD DHC FRCS (Urol) FEBU, Principal Investigator, Consultant Urological Surgeon, Royal Hallamshire Hospital

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