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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: JetTouch Needle-free injection system

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital / Quintiles, Ltd.
  • Sheffield, United Kingdom
    • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: American Medical Systems
• Collaborators: Quintiles, Inc.
• Investigators: Principal Investigator: Christopher R Chapple, BSc MD DHC FRCS (Urol) FEBU, Consultant Urological Surgeon, Royal Hallamshire Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: May 20, 2013
• First Submitted That Met QC Criteria: May 23, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Estimate): June 2, 2014
• Last Update Submitted That Met QC Criteria: May 30, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: OT1202