JetTouch Injection System to Deliver Saline Into the Blad... | NCT01862601

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

NCT01862601

Sponsor

American Medical Systems

Status

Completed

Last Update Posted

Jun 2, 2014Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

JetTouch Needle-free injection system

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

May 20, 2013

First Submission Date that Met QC Criteria

May 23, 2013

First Posted Date

May 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2014

Last Update Posted Date

Jun 2, 2014Estimated

Name	Class
Quintiles, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
JetTouch injections	Experimental		Device: JetTouch Needle-free injection system

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

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
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Guy's Hospital / Quintiles, Ltd.		London		SE1 9RT	United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust