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

NCT01862601 | Completed Phase 1 DMC

• 1 other identifier: OT1202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

JetTouch injections

EXPERIMENTAL

Device: JetTouch Needle-free injection system

Interventions

JetTouch Needle-free injection system DEVICE

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

JetTouch injections

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals (male and female) aged 18-55 without urinary complaints or documented urinary tract dysfunctions.

You may not qualify if:

• 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

Sponsors & Collaborators

• American Medical Systems: lead
• Quintiles, Inc.: collaborator

Study Sites (2)

Guy's Hospital / Quintiles, Ltd.

London, SE1 9RT, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

Study Officials

• Christopher R Chapple, BSc MD DHC FRCS (Urol) FEBU

  Consultant Urological Surgeon, Royal Hallamshire Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 24, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

GB (2)