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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862601
• Other study ID #: OT1202
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2013
• Last updated: May 30, 2014
• Start date: September 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: American Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Guy's Hospital / Quintiles, Ltd.	London
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
American Medical Systems	Quintiles, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the JetTouch system to deliver saline into the bladder wall.		within 14 days of the JetTouch procedure	Yes
Primary	Ability of the JetTouch system to deliver saline into the bladder wall.		At the JetTouch procedure	No
Secondary	Physician feedback on the use of the JetTouch system.		At the JetTouch Procedure	No
Secondary	Physician feedback on perceived subject tolerability of the JetTouch injection procedure.		At the JetTouch procedure.	No
Secondary	Subject feedback question regarding the procedure.		At the JetTouch procedure	No